Identity
- Trade Name
- HU-FRIEDY FDA UDI
- Generic Name
- Manual dental burnisher, reusable FDA UDI
- Device Name
- B12 BURNISHER DE FDA UDI
- Model / Reference
- BB1293 FDA UDI
- Description
- B12 BURNISHER DE FDA UDI
Identifiers
- Catalog Number
- BB1293 FDA UDI
- Primary DI / UDI-DI
- 10889950041564 FDA UDI
- FDA Product Code
- EKJ FDA UDI
- GMDN Term
- Manual dental burnisher, reusable 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Manual dental burnisher, reusable
Hu-Friedy by Hu-Friedy Mfg Co., Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual dental burnisher, reusable.
- Nivo — B. Ali Impex · Class I
- A. Titan Instruments — A.Titan Instruments · Class I
- BMT Medizintechnik GmbH — BMT Medizintechnik GmbH · Class I
- Karl Schumacher — KARL SCHUMACHER DENTAL, LLC · Class I
- Power Dental USA — Power Dental USA, Inc. · Class I
- American Eagle Instruments — American Eagle Instruments · Class I
- BMT Medizintechnik GmbH — BMT Medizintechnik GmbH · Class I
- LMDental — LM-Dental · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hu-Friedy Mfg Co., Llc
Sources (1)
- FDA UDI 846499f6-ca61-400c-8fd3-cd7f1aeca984 35 fields · synced Jun 1, 2026