Identity
- Trade Name
- Perio-Mate FDA UDI
- Generic Name
- Dental abrasive air jet system handpiece FDA UDI
- Model / Reference
- PER-M4-P FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04589551391141 FDA UDI
- 510(k) Number
- K241880 FDA UDI
- FDA Product Code
- EFB FDA UDI
- GMDN Term
- Dental abrasive air jet system handpiece FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental abrasive air jet system handpiece
Perio-Mate by Nakanishi Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental abrasive air jet system handpiece.
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- AIR-FLOW — E.M.S. Electro Medical Systems S.A. · Class I
- AIR-FLOW — E.M.S. Electro Medical Systems S.A. · Class I
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Cleared under the same submission
K241880 also covers:
- Blower Nozzle — NAKANISHI INC.
- Blower Nozzle — NAKANISHI INC.
- Blower Nozzle — NAKANISHI INC.
- Cleaning Brush — NAKANISHI INC.
- Cleaning File — NAKANISHI INC.
- Cleaning Wire — NAKANISHI INC.
- Cleaning Wire — NAKANISHI INC.
- Nozzle Tip Remover — NAKANISHI INC.
- PER-HP — NAKANISHI INC.
- Perio-Mate — NAKANISHI INC.
- Perio-Mate — NAKANISHI INC.
- Ring Wrench — NAKANISHI INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Nakanishi Inc.
Sources (1)
- FDA UDI cb332512-d058-4d0e-9046-5899ddb45769 33 fields · synced May 30, 2026