Identity
- Trade Name
- MASTER PROPHY AIRLITE FDA UDI
- Generic Name
- Dental surgical power tool motor, pneumatic FDA UDI
- Device Name
- The Prophy Airlite is a quick disconnect pneumatic dental handpiece which accepts prophy angles, has premium ball bearings, and operates at a speed of 3500 RPMs. It is used for polishing teeth and used by professional hygienists and dentists in a dental setting. FDA UDI
- Model / Reference
- 50154-03 FDA UDI
- Description
- The Prophy Airlite is a quick disconnect pneumatic dental handpiece which accepts prophy angles, has premium ball bearings, and operates at a speed of 3500 RPMs. It is used for polishing teeth and used by professional hygienists and dentists in a dental setting. FDA UDI
Identifiers
- Primary DI / UDI-DI
- D8265015403 FDA UDI
- 510(k) Number
- K070001 FDA UDI
- FDA Product Code
- EFB FDA UDI
- GMDN Term
- Dental surgical power tool motor, pneumatic 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental surgical power tool motor, pneumatic
Master Prophy Airlite by Mti Precision Products — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental surgical power tool motor, pneumatic.
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- MK-dent — MK-Dent GmbH · Class I
- AM-20 E RM — W & H Dentalwerk Bürmoos GmbH · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- SABLE - Hygienist Package — Sable Industries Inc · Class I
- SABLE - Hygienist Package — Sable Industries Inc · Class I
- TA Bulb — NAKANISHI INC. · Class I
Cleared under the same submission
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
- Mti Precision Products
Sources (1)
- FDA UDI 377f9e5e-7251-4afa-b9a6-52f3d720e812 34 fields · synced May 29, 2026