Identity
- Trade Name
- Azure FDA UDI
- Generic Name
- Dental implant abutment analog, laboratory FDA UDI
- Device Name
- Internal Hex MI FDA UDI
- Model / Reference
- 17.082 FDA UDI
- Description
- Internal Hex MI FDA UDI
Identifiers
- Catalog Number
- ARMSCV-ICD37 FDA UDI
- Primary DI / UDI-DI
- 08435457299943 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental implant abutment analog, laboratory FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
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 abutment analog, laboratory
Azure by Terrats Medical Sl. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant abutment analog, laboratory.
- Medentika — Medentika GmbH · Class I
- Paltop — Paltop Advanced Dental Solutions, Ltd. · Class I
- AXIOM® — ETABLISSEMENTS ANTHOGYR · Class I
- DYNAMIC ABUTMENT SOLUTIONS — TALLADIUM ESPAÑA SL · Class I
- DYNAMIC ABUTMENT® SOLUTIONS — TALLADIUM ESPAÑA SL · Class I
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC. · Class I
- TITAN IMPLANTS, INC. — TITAN IMPLANT INC · Class I
- Lab Analog 10PK, Paltop (IHex) — SMART DENTURE CONVERSIONS, LLC · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Terrats Medical Sl.
Sources (1)
- FDA UDI 394830f6-b2c4-4ff2-a209-8f888ed5a931 35 fields · synced May 30, 2026