{"hq_id":"hq-p-spe-000091","name":"Dental Composite Filling (BPA/bis-GMA Leaching)","category":{"primary":"specialty","secondary":"dental","tags":["dental composite","BPA","bis-GMA","filling","resin","mercury-free","alternative"]},"product_tier":"SPE","overall_risk_level":"low","description":"Tooth-colored composite resin fillings using bis-GMA (bisphenol A-glycidyl methacrylate) — a BPA derivative. Small amounts of BPA can leach from newly placed composites. ADA: BPA exposure from dental composites is 'far below the level that might cause adverse health effects.' BPA release is highest in first 24 hours after placement, then drops to negligible. Composites are the mercury-free alternative to amalgam — trading theoretical BPA concern for eliminated mercury concern.","synthesis":{"derived_risk_level":"moderate_to_high","synthesis_confidence":0.574,"synthesis_method":"compound_composition","context_used":"human_child","context_source":"product_users","exposure_modifier":1.38,"vulnerability_escalated":true,"escalation_reason":"Child exposure group","compounds_resolved":2,"compounds_total":2,"synthesis_date":"2026-05-09","synthesis_version":"1.2.0","methodology_note":"exposure_modifier and adjusted_magnitude are computed from ALETHEIA-calibrated heuristics (route × duration × frequency multipliers, clamped to [0.5, 1.4]). Multipliers are directionally informed by EPA Exposure Factors Handbook (2011) and CalEPA OEHHA but are not regulatory consensus. See /api/methodology for full disclosure."},"hazard_summary":{"sensitive_populations":"children (higher BPA per body weight)","overall_risk":"low","primary_concerns":["BPA leaching from bis-GMA resin (ppb levels, highest first 24 hours)","Multiple fillings increase cumulative BPA exposure","Mercury-free alternative to amalgam — overall safer profile","BPA-free composite alternatives exist (ormocer technology)"],"exposure_routes":"Oral (saliva contact with composite surface)"},"exposure":{"routes":["oral"],"contact_types":["oral_direct"],"users":["adult","child"],"duration":"continuous","frequency":"daily","scenarios":["BPA leaching from newly placed composite (highest first 24 hours)","Long-term low-level BPA release from composite surface","Multiple composite fillings increasing cumulative BPA exposure","Children: higher BPA per body weight from dental composites"],"notes":"ADA 2021: 'based on current evidence, ADA continues to support dental sealants and composites as safe treatment options.' BPA release from composites: 0.1-1 ppb in saliva (first 24 hours), dropping to <0.01 ppb after 1 week. For comparison: BPA from a single canned food serving: 1-5 ppb. Rinsing mouth after composite placement reduces acute BPA exposure by 90%. BPA-free composites (Admira Fusion — ormocer technology) are available."},"consumer_guidance":{"usage_warning":"BPA from dental composites is far below adverse effect level (ADA). Rinse mouth thoroughly after composite placement (reduces acute BPA 90%). Ask dentist about BPA-free composite options (Admira Fusion). Composite IS the safer alternative to mercury amalgam overall.","safer_alternatives":["BPA-free ormocer composites (Admira Fusion — VOCO)","Glass ionomer cement (mercury-free, BPA-free, releases fluoride)","Ceramic inlays/onlays (zero resin, zero BPA)","Composite IS the safer alternative to amalgam mercury"],"red_flags":[{"indicator":"Health claims without FDA approval or clinical evidence","meaning":"Product efficacy unverified.","action":"Consult physician. Check FDA and clinical trial evidence."}],"green_flags":[{"indicator":"FDA-approved, USP-verified, or physician-recommended","meaning":"Verified safety and/or efficacy through established evaluation.","verification":"Check FDA approval status, USP mark, or published clinical evidence."}],"what_to_ask":[{"question":"Is there FDA-approved or peer-reviewed clinical evidence for this product?","why_it_matters":"Health products without evidence may be ineffective or harmful.","good_answer":"FDA-approved or supported by published RCTs.","bad_answer":"Testimonials only or DSHEA-exempt supplement with no clinical evidence."}],"alternatives":[{"name":"BPA-free ormocer composites","notes":"Admira Fusion — VOCO"},{"name":"Glass ionomer cement","notes":"mercury-free, BPA-free, releases fluoride"},{"name":"Ceramic inlays/onlays","notes":"zero resin, zero BPA"}]},"regulatory":{"applicable_regulations":[{"jurisdiction":"USA","regulation":"FDA Class II Medical Device (dental composites)","citation":"21 CFR 872.3275","requirements":"Dental restorative materials classified as Class II. Pre-market notification (510(k)) required.","compliance_status":null,"effective_date":null,"enforcing_agency":"FDA","penalties":null,"source_ref":null}],"certifications":[],"labeling":{"required_disclosures":[],"prop65_warning":{"required":null,"chemicals":[],"endpoint":null,"notes":null},"ghs_labeling":{"required":null,"signal_word":null,"pictograms":[],"hazard_statements":[],"notes":null},"hidden_ingredients":{"trade_secret_protected":null,"categories_hidden":[],"estimated_count":null,"known_concerns":null,"notes":null},"notes":null},"recalls":[],"regulatory_gap":null,"notes":null},"lifecycle":{"recyclable":false,"disposal_guidance":"Dental waste per practice protocols.","hazardous_waste":false,"expected_lifespan":"5-15_years"},"formulation":{"form":"varies","key_ingredients":[{"hq_id":"hq-c-org-000648","name":"BADGE (bisphenol A diglycidyl ether)","role":"resin_base","concentration_pct":"varies"},{"hq_id":"hq-c-org-000006","name":"Bisphenol A","role":"leaching_trace","concentration_pct":"trace (ppb)"}],"certifications":[]},"materials":{"common":[],"concerning":[],"preferred":[]},"compound_composition":[{"hq_id":"hq-c-org-000648","compound_name":null,"role":"resin_base","typical_concentration":"varies"},{"hq_id":"hq-c-org-000006","compound_name":null,"role":"leaching_trace","typical_concentration":"trace (ppb)"}],"identifiers":{"common_names":["dental composite filling (bpa/bis-gma leaching)"],"aliases":[],"manufacturer":null,"brands":[]},"brand_examples":[{"brand":"Del Monte","manufacturer":"Del Monte Foods","market_position":"mass_market","notable":"Major canned food brand"},{"brand":"Campbell's","manufacturer":"Campbell Soup","market_position":"mass_market","notable":"Iconic canned soup brand"},{"brand":"Amy's Kitchen","manufacturer":"Amy's Kitchen","market_position":"premium","notable":"BPA-free lined organic canned foods"}],"brand_examples_disclaimer":"Representative branded products of this category. Concerning ingredients listed in materials.concerning[] apply to the category, not necessarily to every named brand. Specific formulations vary by SKU and may have changed since this record was written; consult the brand's current ingredient label before drawing brand-level conclusions.","sources":[{"type":"expert_curation","name":"ALETHEIA Safety Database","date":"2026-03-25"},{"type":"regulation","title":"FDA Class II Medical Device (dental composites) (21 CFR 872.3275)","jurisdiction":"USA","citation":"21 CFR 872.3275","id":"src_128b3d40"},{"id":"src_001","type":"database","title":"PubChem Compound CID 2286","url":"https://pubchem.ncbi.nlm.nih.gov/compound/2286","accessed":"2026-03-12","notes":"Chemical identity, properties, safety data","inherited_from_compound":"hq-c-org-000648"},{"id":"src_002","type":"epa","title":"EPA CompTox Chemicals Dashboard — DTXSID6024624","url":"https://comptox.epa.gov/dashboard/chemical/details/DTXSID6024624","accessed":"2026-03-12","notes":"Hazard, exposure, and toxicity data","inherited_from_compound":"hq-c-org-000648"},{"type":"regulatory","citation":"EFSA CEP Panel. Re-evaluation of the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs. EFSA Journal 2023;21(4):6857.","url":"https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2023.6857","date":"2023-04-19","id":"efsa_2023","inherited_from_compound":"hq-c-org-000006"},{"type":"regulatory","citation":"ECHA Member State Committee. Identification of BPA as SVHC.","date":"2017-06-16","id":"echa_svhc_2017","inherited_from_compound":"hq-c-org-000006"}],"meta":{"schema_version":"4.0.0","last_updated":"2026-03-25","timestamp":"2026-05-14T01:22:49.906Z"}}