Identity
- Trade Name
- Ditron Dental FDA UDI
- Generic Name
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- TLI Open Tray Impression Post, Crown FDA UDI
- Model / Reference
- TLI-TR650 FDA UDI
- Description
- TLI Open Tray Impression Post, Crown FDA UDI
Identifiers
- Catalog Number
- TLI-TR650 FDA UDI
- Primary DI / UDI-DI
- 07290109288109 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Ditron Dental by Ditron Dental Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental/maxillofacial surgical procedure kit, non-medicated, reusable.
- Dental Elevator Combo Set — SONTEC INSTRUMENTS, INC. · Class I
- Positioning Guide Full KIT — OSSTEM IMPLANT CO., LTD. · Class IIa
- Implantium, Superline — Dentium Co., Ltd. · Class I
- Bone Management — Hager & Meisinger Gesellschaft mit beschränkter Haftung · Class I
- KLOCKNER — SOADCO, S.L. · Class II
- HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
- Osteo KIT — OSSTEM IMPLANT Co., Ltd. · Class I
- UniFit-Standard Internal Star Plastic Surgical Kit-Advanced — ADIN DENTAL IMPLANT SYSTEMS LTD. · Class IIa
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ditron Dental Ltd
Sources (1)
- FDA UDI 23db3205-7ff2-4e67-a8b4-464501cf7bcc 35 fields · synced Jun 8, 2026