Ipd
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Custom Ti Base Engaging Ø 4,8 H 0.2 EUDAMEDIPD FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Hollow Screw System ; Custom Interface System ; Cerec Sirona Ti Base System EUDAMEDEngaging Interface Ø 4.8 h 0.2 mm 3D FDA UDI
- Model / Reference
- IN / INC3D / INSI EUDAMEDIPD/AB-IR-00/3D EUDAMEDINC3D FDA UDI
- Description
- Engaging Interface Ø 4.8 h 0.2 mm 3D FDA UDI
Identifiers
- Catalog Number
- IPD/AB-IR-00/3D FDA UDI
- Primary DI / UDI-DI
- 08435566601293 EUDAMEDFDA UDI
- Basic UDI-DI
- 8435566603BQ EUDAMED
- 510(k) Number
- K222215 FDA UDI
- FDA Product Code
- NHA FDA UDIPNP FDA UDI
- EMDN Code
- Q01020602 COMBINED DENTAL PROSTHESES 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
- Spain 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
Yes
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
Ipd by Implant Protesis Dental 2004 Sl — 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
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- 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
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 (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 |
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Manufacturer
- Manufacturer
- Implant Protesis Dental 2004 Sl
Sources (2)
- FDA UDI 3c8f82e3-5279-46ad-bd54-1c8d98b05eba 36 fields · synced Jul 13, 2026
- EUDAMED 97a8c2d7-c440-412e-8c68-48663dc21324 61 fields · synced Jul 13, 2026