Identity
- Trade Name
- Cemented Abutment Mini FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Model / Reference
- SACH4517M FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800055761541 FDA UDI
- 510(k) Number
- K240091 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Dental implant suprastructure, temporary, preformed, single-use
Cemented Abutment Mini by ARUM DENTISTRY Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
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- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
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- Falcon — Falcon Surgical Co. (Pvt.) Ltd · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Neoss Implant System — Neoss, Ltd. · Class II
- Scanbody Screw — ARUM DENTISTRY Co., Ltd. · Class I
Cleared under the same submission
K240091 also covers:
- Angled Abutment Mini — ARUM DENTISTRY Co., Ltd.
- Angled Abutment Mini — ARUM DENTISTRY Co., Ltd.
- Angled Abutment Mini — ARUM DENTISTRY Co., Ltd.
- Angled Abutment Mini — ARUM DENTISTRY Co., Ltd.
- Angled Abutment Mini — ARUM DENTISTRY Co., Ltd.
- Angled Abutment Mini — ARUM DENTISTRY Co., Ltd.
- Cemented Abutment Mini — ARUM DENTISTRY Co., Ltd.
- Cemented Abutment Mini — ARUM DENTISTRY Co., Ltd.
- Cemented Abutment Mini — ARUM DENTISTRY Co., Ltd.
- Cemented Abutment Mini — ARUM DENTISTRY Co., Ltd.
- Cemented Abutment Mini — ARUM DENTISTRY Co., Ltd.
- Cemented Abutment Mini — ARUM DENTISTRY Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- ARUM DENTISTRY Co., Ltd.
Sources (1)
- FDA UDI 1f5e419b-5baa-41e1-963a-8ff11f51ff92 33 fields · synced May 30, 2026