Identity
- Trade Name
- KERR FDA UDI
- Generic Name
- Dental power tool system handpiece, line-powered FDA UDI
- Device Name
- KERR Endodontic System EUDAMEDHANDPIECE, DIRECT DRIVE, AC-POWERED (CONSOLE) FDA UDI
- Model / Reference
- AEU-28KER-2 EUDAMEDAEU-28KER FDA UDI
- Description
- HANDPIECE, DIRECT DRIVE, AC-POWERED (CONSOLE) FDA UDI
Identifiers
- Catalog Number
- AEU-28KER FDA UDI
- Primary DI / UDI-DI
- 10817417020043 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10817417020043 EUDAMED
- FDA Product Code
- EKX FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental power tool system handpiece, line-powered FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 8 Pound FDA UDI
KERR Endodontic System by Aseptico, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10817417020043 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Aseptico, Inc.
- EUDAMED SRN
- US-MF-000014012
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 740a76aa-2e3f-4327-9114-b81dbcb19b70 61 fields · synced Jul 9, 2026
- FDA UDI 6b667931-46c2-4b60-882b-a54836b4bec5 38 fields · synced May 30, 2026