Identity
- Trade Name
- J & J INSTRUMENTS INC FDA UDI
- Generic Name
- Manual dental burnisher, reusable FDA UDI
- Device Name
- BURNISHER SE #28 FDA UDI
- Model / Reference
- 02-528 FDA UDI
- Description
- BURNISHER SE #28 FDA UDI
Identifiers
- Catalog Number
- 02-528 FDA UDI
- Primary DI / UDI-DI
- 00817524020724 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
Dimensions & Sizes
- Size
- Length — 5.875 Inch FDA UDI
Category: Manual dental burnisher, reusable
J & J Instruments Inc by J&J Instruments, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- J&J Instruments, LLC
Sources (1)
- FDA UDI 92e0d960-b6c9-4137-af99-8ac458a43e01 35 fields · synced Jun 9, 2026