Identity
- Trade Name
- Prehma FDA UDI
- Generic Name
- Dental delivery system irrigation handpiece tip FDA UDI
- Device Name
- Disposable Air/Water Syringe Tips White (250/bag) FDA UDI
- Model / Reference
- 10-04510 FDA UDI
- Description
- Disposable Air/Water Syringe Tips White (250/bag) FDA UDI
Identifiers
- Catalog Number
- 10-04510 FDA UDI
- Primary DI / UDI-DI
- H66810045101 FDA UDI
- FDA Product Code
- ECB FDA UDI
- GMDN Term
- Dental delivery system irrigation handpiece tip FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental delivery system irrigation handpiece tip
Prehma by Keystone Industries — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental delivery system irrigation handpiece tip.
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- Access-Tips -Package of 3 — Hager Worldwide, Inc. · Class I
- Unipack — Unipack Medical Corporation · Class I
- Health-Tec/DHP Air/Water Syringe Tips — Dental Health Products Inc · Class I
- Access-Tips -Package of 25 — Hager Worldwide, Inc. · Class I
- Health-Tec/DHP Syringes — Dental Health Products Inc · Class I
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
- Keystone Industries
Sources (1)
- FDA UDI 4a4167a0-7912-44f4-a5cf-9b3c6a0ee39e 35 fields · synced Jun 9, 2026