Identity
- Trade Name
- Customized Abutment FDA UDI
- Generic Name
- Shoulder immobilizer/orthosis, single-use FDA UDI
- Model / Reference
- CIHE006S FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809924584472 FDA UDI
- 510(k) Number
- K223634 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Shoulder immobilizer/orthosis, 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
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Category: Shoulder immobilizer/orthosis, single-use
Customized Abutment by ARUM DENTISTRY Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Shoulder immobilizer/orthosis, single-use.
- VELPEAU IMMOBILIZER LG — BIRD & CRONIN, LLC · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- BICRO SHLDR IMMOB ELASTIC 43-47" 2XL — BIRD & CRONIN, LLC · Class I
- B-COOL SHOULDER WRAP ONLY — BIRD & CRONIN, LLC · Class I
- VELPEAU IMMOBILIZER XS — BIRD & CRONIN, LLC · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- B-COOL SHOULDER COLD KIT — BIRD & CRONIN, LLC · Class I
- MESH VELPEAU SHOULDER IMMOB LG — BIRD & CRONIN, LLC · Class I
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 (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 77532b7a-0836-401a-ac07-26e669ba3547 33 fields · synced Jun 8, 2026