Identity
- Trade Name
- Healing Abutment FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Model / Reference
- HA5507GR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809917604316 FDA UDI
- 510(k) Number
- K222131 FDA UDI
- FDA Product Code
- DZE FDA UDINHA FDA UDI
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI872.3630 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
Healing Abutment 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
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Retaining Screw for Digital Model Analog — ADIN DENTAL IMPLANT SYSTEMS LTD. · Class I
- 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
K222131 also covers:
- Cemented Abutment — ARUM DENTISTRY Co., Ltd.
- Cemented Abutment — ARUM DENTISTRY Co., Ltd.
- Cemented Abutment — ARUM DENTISTRY Co., Ltd.
- Cemented Abutment — ARUM DENTISTRY Co., Ltd.
- Cemented Abutment — ARUM DENTISTRY Co., Ltd.
- Cemented Abutment — ARUM DENTISTRY Co., Ltd.
- Cemented Abutment — ARUM DENTISTRY Co., Ltd.
- Cemented Abutment — ARUM DENTISTRY Co., Ltd.
- Cemented Abutment — ARUM DENTISTRY Co., Ltd.
- Cemented Abutment — ARUM DENTISTRY Co., Ltd.
- Cemented Abutment — ARUM DENTISTRY Co., Ltd.
- Cemented Abutment — 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 d1aeb49d-09e2-4443-9905-52fb0b482d9e 33 fields · synced Jun 7, 2026