Mitek Mini Anchor
510(k) K992623
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK992623 | Date2 Nov 1999 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DZL
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.4880
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
The Mitek Mini Anchor is an intraosseous fixation screw. It is designed to function as a medical device for the secure attachment of materials within bone.
This device is authorized under FDA 510(k) clearance K992623. It is categorized under the dental medical specialty and is regulated under 21 CFR 872.4880.
Other devices from Mitek Products
Questions
AI-generated answers, 25 Sep 2026
What is the primary function of the Mitek Mini Anchor?
The Mitek Mini Anchor is an intraosseous fixation screw designed to provide secure attachment of materials within bone structures.
Under which medical specialty is this device categorized?
This device is categorized under the dental medical specialty and is regulated under 21 CFR 872.4880.
Is the Mitek Mini Anchor authorized for use?
Yes, the device is authorized under FDA 510(k) clearance number K992623, which indicates it has been found substantially equivalent to legally marketed predicate devices.