Identity
- Trade Name
- BURNISHER HOLLENBACK 6 EUDAMEDAmerican Eagle Instruments FDA UDI
- Generic Name
- Manual dental burnisher, reusable FDA UDI
- Device Name
- Burnisher EUDAMEDBURNISHER HOLLENBACK 6 FDA UDI
- Model / Reference
- AEBH6 EUDAMEDFDA UDI
- Description
- BURNISHER HOLLENBACK 6 FDA UDI
Identifiers
- Catalog Number
- AEBH6 FDA UDI
- Primary DI / UDI-DI
- 00841013102004 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841013164078EKKD169678HL EUDAMED
- FDA Product Code
- EKK FDA UDI
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
- GMDN Term
- Manual dental burnisher, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Dental appliance fabrication material, ceramic
Burnisher Hollenback 6 by American Eagle Instruments — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0841013164078EKKD169678HL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- American Eagle Instruments
- EUDAMED SRN
- US-MF-000018222
- Authorised Representative
- Young Microbrush Ireland Ltd IE-AR-000011249
Sources (2)
- EUDAMED b5536e6f-538b-4db8-a032-d7aff8259514 61 fields · synced Jun 18, 2026
- FDA UDI 1dee96cc-5b36-4bea-89cc-c544ac9f4729 34 fields · synced May 30, 2026