Saw, Bone, Ac-Powered
The AC-Powered Bone Saw is a dental and oral surgical device used to cut bone tissue during oral and maxillofacial surgical procedures, driven by alternating current electrical power. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) clearance before marketing. The product code is DZH and the applicable regulation is 21 CFR 872.4120, under the Dental medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- DZH
- Device Class
- FDA class 2
- Regulation Number
- 872.4120
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 1
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 |
|---|---|---|---|---|
| K031793 | DENTATUS OSCIOMAT | Nov 13, 2003 | Substantially Equivalent | Dentatus USA , Ltd. |
| K935443 | ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS | Sep 20, 1994 | Substantially Equivalent | Osada Electric Co., Ltd. |
| K760958 | SURGICAL OSCILLATING SAW | Nov 16, 1976 | Substantially Equivalent | American Safety Equipment Corp. |
| K760957 | SURGICAL RECIPROCATING SAW | Nov 15, 1976 | Substantially Equivalent | American Safety Equipment Corp. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.