Identity
- Trade Name
- Tapered Screw-Vent® EUDAMEDFDA UDI
- Generic Name
- Dental implant analog FDA UDI
- Device Name
- Dental Laboratory Tools EUDAMED
- Model / Reference
- IA4 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889024015494 EUDAMEDFDA UDI
- Basic UDI-DI
- 844868ABHS EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Dental implant analog FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental implant analog
Tapered Screw-Vent® by Zimmer Dental Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant analog.
- Digital Lab Analog Screw — DENTIS CO. , LTD · Class I
- Blue Sky Bio, LLC — BLUE SKY BIO LLC · Class I
- DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM — DIO Corporation · Class I
- One Stage TL S — I3 IMPLANT LLC · Class II
- Blue Sky Bio, LLC — BLUE SKY BIO LLC · Class I
- DYNAMIC ABUTMENT® SOLUTIONS — TALLADIUM ESPAÑA SL · Class I
- ANALOG — DENTIN IMPLANTS TECHNOLOGIES LTD · Class II
- Elos Accurate® Analog for Printed Models — Elos Medtech Pinol A/S · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Zimmer Dental Inc.
Sources (2)
- FDA UDI c98d7224-89d6-44f2-83a5-3e488400ad96 34 fields · synced Oct 7, 2026
- EUDAMED 7166cdd3-c818-46a2-8fa7-e298d26200b0 61 fields · synced Jul 9, 2026