Forceps, Tooth Extractor, Surgical
The surgical tooth extractor forceps is a hand-held dental instrument used to grip and remove teeth during oral surgical procedures. It is classified as FDA Class 1, meaning it poses the lowest risk and is subject only to general controls without requiring premarket notification. The product code is EMG, regulated under 21 CFR 872.4565, within the Dental medical specialty. This instrument does not carry implant, life-sustaining, GMP-exempt, or third-party review designations.
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Basic Information
- Product Code
- EMG
- Device Class
- FDA class 1
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K062130 | MEISINGER BENEX, MODEL BE001 | Apr 16, 2007 | Substantially Equivalent | Hager& Meisinger GmbH |
| K060691 | EASY X-TRAC SYSTEM | Jun 12, 2006 | Substantially Equivalent | A. Titan Instruments, Inc. |
| K851708 | 500/1 TO 500/80 VARIOUS TYPES OF ENGLISH PAT DENTA | Jul 01, 1985 | Substantially Equivalent | Artiberia |
| K851712 | 600/203 TO 650/74XN VARIOUS TYPES OF DENT EXTRACTI | Jun 11, 1985 | Substantially Equivalent | Artiberia |
| K851711 | 600/7 TO 600/288 VARIOUS TYPES OF AMER. PATTERN DE | Jun 11, 1985 | Substantially Equivalent | Artiberia |
| K851709 | 560 TO 577 VARIOUS TYPES OF FORCEPS FOR CHILDREN | Jun 11, 1985 | Substantially Equivalent | Artiberia |
| K851105 | TOOTH EXTRACTING FORCEPS 151(2010)-875 PCS. SS410/ | May 15, 1985 | Substantially Equivalent | The Huxley Instrument Corp. |
| K840312 | CAT. 8 DENTAL DEVICES | Apr 05, 1984 | Substantially Equivalent | Imm Enterprises , Ltd. |
| K823325 | DENTAL INSTRUMENTS - SURGICAL FORCEPS | Nov 24, 1982 | Substantially Equivalent | Miltex, Inc. |
| K821781 | BEACH FORCEP NO. 150 AND NO. 151 | Jul 02, 1982 | Substantially Equivalent | Pacific Dental Corp. |
FEI Numbers
This FDA classification entry is associated with 203 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 203 registration numbers. Click on an entry to view related FDA registrations.