Chisel, Osteotome, Surgical
The osteotome surgical chisel is a dental instrument specifically designed for bone-splitting or contouring, particularly in procedures such as sinus lifts or alveolar ridge modifications. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is EMM, regulated under 21 CFR 872.4565 in the Dental specialty. No implant, life-sustaining, GMP-exempt, or third-party review designations apply.
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Basic Information
- Product Code
- EMM
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K963897 | STERI-OSS SINUS AUGMENTATION KIT | Nov 06, 1996 | Substantially Equivalent | Steri-Oss, Inc. |
| K864775 | CHISEL (OSTEOTOME, GOUGE, ETC.) | Feb 12, 1987 | Substantially Equivalent | New England Surgical Instrument Corp. |
| K851714 | 820/1 TO 820/51 VARIOUS TYPES BONE RONGEURS | Jun 11, 1985 | Substantially Equivalent | Artiberia |
| K760959 | SURGICAL CHISEL | Nov 15, 1976 | Substantially Equivalent | American Safety Equipment Corp. |
FEI Numbers
This FDA classification entry is associated with 127 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 127 registration numbers. Click on an entry to view related FDA registrations.