Peak Bond, Model 5133
510(k) K063557
Peak Bond, Model 5133 is a Class II device made by Ultradent Products, Inc., cleared under FDA 510(k) K063557 on 12 Dec 2006, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK063557 | Date12 Dec 2006 | StatusActive |
Official records
- FDA 510(k) database K063557
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KLE
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3200
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
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