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File, Bone, Surgical
FDA product code EMI · Class 1 · Dental
337
Registered devices
0
Adverse events
4
Recalls
4
510(k) clearances
Devices with this code
DentaSonic — Gc Orthodontics America Inc.gSource — GSOURCE LLCKarl Schumacher — Karl Schumacher Dental, LLCDentaSonic — Gc Orthodontics America Inc.FILE — KLS-Martin L.P.Brasseler USA — Peter Brasseler Holdings, LLCFILE — KLS-Martin L.P.Sklar® — SKLAR CORPORATIONNordent Manufacturing, Inc. — NORDENT MANUFACTURING INCFILE — KLS-Martin L.P.V. Mueller — STERIS CORPORATIONReicodent — devemed GmbHJ & J INSTRUMENTS INC — J & J INSTRUMENTS INCARKANSAS SHARPENING STONE — SONTEC INSTRUMENTS, INC.Quinelato — Schobell Industrial LtdaSCHWERT — A. Schweickhardt GmbH & Co. KGDentaSonic — Gc Orthodontics America Inc.devemed — devemed GmbHV. Mueller — STERIS CORPORATIONBOSS Instruments — BOSS INSTRUMENTS, LTD., INC.DentaSonic — Gc Orthodontics America Inc.FILE — KLS-Martin L.P.Sklar® — SKLAR CORPORATIONSklar® — SKLAR CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-04-26 | Meta C.G.M. Spa | Sterility issues; single use devices labeled as sterile may not have been adequately sterilized |
| 2021-04-26 | Meta C.G.M. Spa | Sterility issues; single use devices labeled as sterile may not have been adequately sterilized |
| 2021-04-26 | Meta C.G.M. Spa | Sterility issues; single use devices labeled as sterile may not have been adequately sterilized |
| 2021-04-26 | Meta C.G.M. Spa | Sterility issues; single use devices labeled as sterile may not have been adequately sterilized |
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