Ipd
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Custom Ti Base Engaging Ø 4,3 H 1.5 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 EUDAMEDCustom Ti Base Engaging Ø 4,3 H 1.5 FDA UDI
- Model / Reference
- IN / INC3D / INSI EUDAMEDIPD/AD-IR-02/3D EUDAMEDINC3D FDA UDI
- Description
- Custom Ti Base Engaging Ø 4,3 H 1.5 FDA UDI
Identifiers
- Catalog Number
- IPD/AD-IR-02/3D FDA UDI
- Primary DI / UDI-DI
- 08435566603525 EUDAMEDFDA UDI
- Basic UDI-DI
- 8435566603BQ EUDAMED
- 510(k) Number
- K231413 FDA UDI
- FDA Product Code
- PNP FDA UDINHA 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
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Cleared under the same submission
K231413 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 03b33d26-21e8-4944-af3e-fae4e249b40e 36 fields · synced Jul 9, 2026
- EUDAMED 97784a39-2b50-442c-90d2-8333fe0bac92 61 fields · synced Jul 9, 2026