Ditron Dental
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Casting Abutment EUDAMEDDitron Dental FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Plastic Disk for Ball Attachment EUDAMEDSt. Casting Esthetic Abutment Plastic H3mm FDA UDI
- Model / Reference
- CAP-H30ST EUDAMEDFDA UDIOverdenture Processing Components EUDAMED
- Description
- St. Casting Esthetic Abutment Plastic H3mm FDA UDI
Identifiers
- Catalog Number
- CAP-H30ST FDA UDI
- Primary DI / UDI-DI
- 07290109282527 EUDAMEDFDA UDI
- Basic UDI-DI
- 729010928ACCE9E EUDAMED
- Direct Marketing DI
- 07290109282527 EUDAMED
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
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 suprastructure, temporary, preformed, single-use
Ditron Dental by Ditron Dental Ltd — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
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- Neoss Implant System — Neoss, Ltd. · Class II
- Scanbody Screw — ARUM DENTISTRY Co., Ltd. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ditron Dental Ltd
Sources (2)
- FDA UDI 5191bb14-96ba-4523-8da8-2d0b7f604d96 35 fields · synced Jul 9, 2026
- EUDAMED 95e19bac-67fc-4107-acd5-6ee2e2c90ab9 61 fields · synced Jul 9, 2026