SYBRON DENTAL SPECIALTIES, INC.
2 recall(s) on record — most severe on record: Class II.
Recalls by year
- Recalls (2)
Registered facilities (17)
- Ormco Corporation FEI 2024258 · CA
- Envista (Sichuan) Medical Device Co., Ltd. FEI 3031606517 · CN
- Kerr Corporation FEI 3012477813 · CA
- EH Labs CZ s.r.o. FEI 3028340833 · CZ
- Kerr Italia, S.r.l. FEI 1000231788 · IT
- Kerr Corporation FEI 2024312 · CA
- Metrex Research LLC FEI 3003848022 · WI
- Ormex S. de R.L. de C.V. FEI 3002807826 · MX
- SDS de Mexico S. de R.L. de C.V. FEI 3000368601 · MX
- Ormco Corporation FEI 3015272949 · CA
- Envista (Suzhou) Medical Device Co., Ltd. FEI 3045923493 · CN
- Allesee Orthodontic Appliances, Inc. FEI 1000128562 · WI
- METREX RESEARCH FEI 1000117344 · MI
- Envista (Suzhou) Medical Device Co., Ltd. FEI 3014749460 · CN
- SpofaDental a.s. FEI 3007743883 · CZ
- Kerr Corporation FEI 3032378317 · CA
- EH Dental Services Costa Rica Sociedad de Responsabilidad Limitada FEI 3027500898 · CR
Recalls & enforcement
- Class IITerminated2015-02-11Cases of Cure Sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes labeled with part number 4500 which fit 7mm and 8mm tips. There is a low risk associated with the use of the product as the sleeve may tear causing a potential for cross contamination.
- Class IITerminated2013-06-06The firm initiated the recall of AOA Mini RPE Screw Assembly, because it may be missing a complete weld joining one side of the arm with the screw body. Herbst, MARA and Fixed Metal devices may be affected, because they contain an AOA Mini RPE Screw Assembly.
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “SYBRON DENTAL SPECIALTIES, INC. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9029565-sybron-dental-specialties-inc/
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