Identity
- Trade Name
- Pre-milled Blank EUDAMEDCustomized Abutment FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Abutment and Abutment screw EUDAMED
- Model / Reference
- CIHE008 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800055715452 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000557CADCAMAY EUDAMED
- 510(k) Number
- K223634 FDA UDI
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class IIb 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
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
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
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Dental implant suprastructure, permanent, preformed
Customized Abutment by ARUM DENTISTRY Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, permanent, preformed.
- SPARE CAST. SLEEVE FOR — SWEDEN & MARTINA INC · Class II
- HS/HG Prosthetic System — OSSTEM IMPLANT Co., Ltd. · Class II
- DESS dental smart solutions — TERRATS MEDICAL SL. · Class II
- Diamodent — Diamodent · Class II
- Cemented Abutment — POINTIMPLANT Co., Ltd. · Class II
- GS System — OSSTEM IMPLANT Co., Ltd. · Class II
- Temporary Abutment — Cybermed Inc. · Class II
- EZ Post — Megagen Implant Co. Ltd · Class II
Cleared under the same submission
K223634 also covers:
- Cemented Abutment — ARUM DENTISTRY Co., Ltd.
- Customized Abutment — ARUM DENTISTRY Co., Ltd.
- Customized Abutment — ARUM DENTISTRY Co., Ltd.
- Customized Abutment — ARUM DENTISTRY Co., Ltd.
- Customized Abutment — ARUM DENTISTRY Co., Ltd.
- Customized Abutment — ARUM DENTISTRY Co., Ltd.
- Customized Abutment — ARUM DENTISTRY Co., Ltd.
- Customized Abutment — ARUM DENTISTRY Co., Ltd.
- Customized Abutment — ARUM DENTISTRY Co., Ltd.
- Customized Abutment — ARUM DENTISTRY Co., Ltd.
- Customized Abutment — ARUM DENTISTRY Co., Ltd.
- Customized Abutment — ARUM DENTISTRY Co., Ltd.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ARUM DENTISTRY Co., Ltd.
Sources (2)
- FDA UDI a4a5bdab-b1eb-418a-8578-51fa25cd00ad 33 fields · synced Oct 6, 2026
- EUDAMED 308819be-b31e-4ed0-9599-6d99cb3286f9 61 fields · synced Oct 6, 2026