Identity
- Trade Name
- Power Dental USA FDA UDI
- Generic Name
- Dental spatula, reusable FDA UDI
- Device Name
- BURNISHERS B28/29 TITANIUM OCTAGON HANDLE FDA UDI
- Model / Reference
- 2820TO FDA UDI
- Description
- BURNISHERS B28/29 TITANIUM OCTAGON HANDLE FDA UDI
Identifiers
- Catalog Number
- 2820TO FDA UDI
- Primary DI / UDI-DI
- D9432820TO00 FDA UDI
- FDA Product Code
- EKJ FDA UDI
- GMDN Term
- Dental spatula, 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
No
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
Power Dental USA by Power Dental USA, 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
- Power Dental USA, Inc.
Sources (1)
- FDA UDI 03e65c0b-5647-42bf-bd8b-b95f7e784bc0 36 fields · synced May 29, 2026