Identity
- Trade Name
- Titanium Trauma Splint, 52 x 0.2mm EUDAMEDMODUS FDA UDI
- Generic Name
- Removable dental occlusal splint, preformed FDA UDI
- Device Name
- Titanium tooth splint (TTS) EUDAMEDTitanium Trauma Splint, 52 x 0.2mm FDA UDI
- Model / Reference
- TTS-1002 EUDAMEDFDA UDI
- Description
- Titanium Trauma Splint, 52 x 0.2mm FDA UDI
Identifiers
- Catalog Number
- TTS-1002 FDA UDI
- Primary DI / UDI-DI
- 07630037866381 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300378017PH EUDAMED
- FDA Product Code
- EJF FDA UDI
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
- GMDN Term
- Removable dental occlusal splint, preformed FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Market of Registration
- Germany 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Removable dental occlusal splint, preformed
Modus by Medartis Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Removable dental occlusal splint, preformed.
- The TMJ System™ — Myofunctional Research Corp. Pty. , Ltd. · Class I
- Restoration, orthodontic — Modern Dental Laboratory (DG) Co., Ltd. · N
- Anti-snoring, splint — Modern Dental Laboratory (DG) Co., Ltd. · Class II
- Denture, restoration, orthodontic, anti-snoring, orthodontic — Modern Dental Laboratory (DG) Co., Ltd. · Class II
- Restoration, splint — Modern Dental Laboratory (DG) Co., Ltd. · N
- Denture, splint — Modern Dental Laboratory (DG) Co., Ltd. · N
- PERF-GRID — Cynosure, LLC · Class I
- splint — Modern Dental Laboratory (DG) Co., Ltd. · N
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
- Medartis Inc.
Sources (2)
- FDA UDI 827d12b4-61c2-4525-8e71-7a8682f852a2 34 fields · synced Jul 10, 2026
- EUDAMED 8295814d-32a4-4647-b60a-f9b7ca41f4ac 61 fields · synced Jul 10, 2026