Identity
- Trade Name
- Impla Clean Plastic Implant Instrument Kit FDA UDI
- Generic Name
- Manual dental scaler, reusable FDA UDI
- Device Name
- Set of four double-ended plastic implant instruments. Each instrument is shaped differently. FDA UDI
- Model / Reference
- 355220 FDA UDI
- Description
- Set of four double-ended plastic implant instruments. Each instrument is shaped differently. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00014081552204 FDA UDI
- FDA Product Code
- EIY FDA UDI
- GMDN Term
- Manual dental scaler, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Impla Clean Plastic Implant Instrument Kit by Hager Worldwide, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Hager Worldwide, Inc.
Sources (1)
- FDA UDI e0debaa4-4b50-46ba-8f4b-5ecb4fe1812b 35 fields · synced Jun 9, 2026