Ditron Dental
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Impression Coping – Transfer EUDAMEDDitron Dental FDA UDI
- Generic Name
- Dental implant abutment analog, intraoral-scanning, single-use FDA UDI
- Device Name
- Abutment Impression Close Tray Transfer EUDAMEDSlim Scan Body Ti-Base Ø3.60 L12 FDA UDI
- Model / Reference
- SBTI-3612 EUDAMEDFDA UDIImpression Coping – Transfer EUDAMED
- Description
- Slim Scan Body Ti-Base Ø3.60 L12 FDA UDI
Identifiers
- Catalog Number
- SBTI-3612 FDA UDI
- Primary DI / UDI-DI
- 07290109283890 EUDAMEDFDA UDI
- Basic UDI-DI
- 729010928TRANGA EUDAMED
- Direct Marketing DI
- 07290109283890 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Dental implant abutment analog, intraoral-scanning, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
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
Yes
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
Yes
Manufacturing Date
Yes
Category: Dental implant abutment analog, intraoral-scanning, single-use
Ditron Dental by Ditron Dental Ltd — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ditron Dental Ltd
Sources (2)
- FDA UDI 17b03fb4-a3e4-4df7-9efb-c43e0e0c15c0 35 fields · synced Jul 15, 2026
- EUDAMED e223af4c-aeb8-4821-b737-247c38e10d84 61 fields · synced Jul 15, 2026