Identity
- Trade Name
- Lares Research FDA UDI
- Generic Name
- Pneumatic dental scaling/debridement system handpiece FDA UDI
- Device Name
- Prophy, Pastel Plus 4 Hole, Silver FDA UDI
- Model / Reference
- Prophy, Pastel Plus FDA UDI
- Description
- Prophy, Pastel Plus 4 Hole, Silver FDA UDI
Identifiers
- Catalog Number
- 11425U FDA UDI
- Primary DI / UDI-DI
- D95011425U0 FDA UDI
- 510(k) Number
- K961163 FDA UDI
- FDA Product Code
- EFB FDA UDI
- GMDN Term
- Pneumatic dental scaling/debridement system handpiece FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Commercial Distribution
- Not 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
Lares Research by Lares Research, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K961163 also covers:
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
- Lares Research, Inc.
Sources (1)
- FDA UDI 27824d9a-7366-4ca1-970d-38e7a3fc8b06 37 fields · synced Jun 1, 2026