Identity
- Trade Name
- ITL Dental FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Model / Reference
- BMA-0040 MLS System Ball Connection, Straight FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817686021188 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Screw endosteal dental implant, two-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 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
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Screw endosteal dental implant, two-piece
A comprehensive 2-3 paragraph SEO description written in clear, natural language. ITL Dental is a high-quality dental implant system designed to provide support and retention for dental prostheses, featuring a two-piece design with an anchorage component and a retention component.
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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 |
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Manufacturer
- Manufacturer
- Emery Enterprises Inc.
Sources (1)
- FDA UDI 50141a08-01f0-498e-8b2a-3c9b790f2528 32 fields · synced Jul 14, 2026