Identity
- Trade Name
- IPD FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Healing abutment Ti Ø 5,1 h 3 mm FDA UDI
- Model / Reference
- TC FDA UDI
- Description
- Healing abutment Ti Ø 5,1 h 3 mm FDA UDI
Identifiers
- Catalog Number
- IPD/AA-DW-03 FDA UDI
- Primary DI / UDI-DI
- 08435566629938 FDA UDI
- 510(k) Number
- K222215 FDA UDI
- FDA Product Code
- NHA FDA UDIPNP 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
Category: Dental implant suprastructure, temporary, preformed, single-use
Ipd by Implant Protesis Dental 2004 Sl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
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- 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
K222215 also covers:
- IPD — IMPLANT PROTESIS DENTAL 2004 SL
- IPD — IMPLANT PROTESIS DENTAL 2004 SL
- IPD — IMPLANT PROTESIS DENTAL 2004 SL
- IPD — IMPLANT PROTESIS DENTAL 2004 SL
- IPD — IMPLANT PROTESIS DENTAL 2004 SL
- IPD — IMPLANT PROTESIS DENTAL 2004 SL
- IPD — IMPLANT PROTESIS DENTAL 2004 SL
- IPD — IMPLANT PROTESIS DENTAL 2004 SL
- IPD — IMPLANT PROTESIS DENTAL 2004 SL
- IPD — IMPLANT PROTESIS DENTAL 2004 SL
- IPD — IMPLANT PROTESIS DENTAL 2004 SL
- IPD — IMPLANT PROTESIS DENTAL 2004 SL
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Implant Protesis Dental 2004 Sl
Sources (1)
- FDA UDI 5c5daaaa-c5b8-49b3-864f-d2e7c606887d 36 fields · synced May 30, 2026