Perio-Mate PER-M4-P
Perio-Mate PER-M4-P is a Class I device made by Nakanishi Inc., cleared under FDA 510(k) K241880 on 20 Sep 2024 and listed in FDA GUDID since 4 Feb 2025 (UDI-DI 04589551391141), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04589551391141 | Date4 Feb 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK241880 | Date20 Sep 2024 | StatusActive |
Official records
- AccessGUDID record 04589551391141
- FDA 510(k) database K241880
Across registries
- FDA 510(k) K241880 decided 20 Sep 2024 Active
- FDA GUDID UDI-DI 04589551391141 listed 4 Feb 2025 Listed
Timeline
- Cleared FDA 510(k) K241880
- Listed FDA GUDID 04589551391141
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Perio-Mate
- Generic name
- Dental abrasive air jet system handpiece
- Model / reference
- PER-M4-P
- Primary DI / UDI-DI
- 04589551391141
- 510(k) Number
- FDA product code
- EFB
- GMDN term
- Dental abrasive air jet system handpiece
- Device class
- Class I
- Regulation number
- 872.4200
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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