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PRO3DURE THERMEO Powder
FDA UDIEUDAMEDClass U (US FDA UDI)
Ref D1010120Model 12090204
Identity
- Trade Name
- THERMEO Powder EUDAMEDPRO3DURE THERMEO Powder FDA UDI
- Generic Name
- Custom-made mouthguard FDA UDI
- Device Name
- Long-Term Splint Materials (CAD/CAM) EUDAMEDTHERMEO Powder FDA UDI
- Model / Reference
- 12090204 EUDAMEDD1010120 EUDAMED340 g Powder - clear transparent FDA UDI
- Description
- THERMEO Powder FDA UDI
Identifiers
- Primary DI / UDI-DI
- EPRCD1010120 EUDAMEDFDA UDI
- Basic UDI-DI
- ++EPRC12090204CX EUDAMED
- 510(k) Number
- K212017 FDA UDI
- FDA Product Code
- MQC FDA UDI
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Custom-made mouthguard FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDU FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
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
Yes
FDA UDI
Category: Custom-made mouthguard
PRO3DURE THERMEO Powder by Pro3Dure Medical — Class U — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Custom-made mouthguard.
- ULTRAFLEX — Astron Dental · Class II
- BENCO — BENCO DENTAL SUPPLY CO. · Class I
- SML — Selane Products, Inc. · U
- Dentek — DenTek Oral Care, Inc. · U
- ASTRON LC — Astron Dental · Class II
- BENCO — BENCO DENTAL SUPPLY CO. · Class I
- SleepRight — Splintek, Inc. · U
- ASTRON 1180 — Astron Dental · Class II
Cleared under the same submission
K212017 also covers:
- CORiTEC Splint Comfort — Pro3Dure Medical
- CORiTEC Splint Comfort — Pro3Dure Medical
- PRO3DURE THERMEO Blank — Pro3Dure Medical
- PRO3DURE THERMEO Blank — Pro3Dure Medical
- PRO3DURE THERMEO Blank — Pro3Dure Medical
- PRO3DURE THERMEO Blank — Pro3Dure Medical
- PRO3DURE THERMEO Blank — Pro3Dure Medical
- PRO3DURE THERMEO Blank — Pro3Dure Medical
- PRO3DURE THERMEO Liquid — Pro3Dure Medical
- PRO3DURE THERMEO Liquid — Pro3Dure Medical
- PRO3DURE THERMEO Liquid — Pro3Dure Medical
- PRO3DURE THERMEO Powder — Pro3Dure Medical
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 U | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Pro3Dure Medical
Sources (2)
- FDA UDI c86e9619-b13f-4045-977a-b3f636d5ad22 35 fields · synced Jul 8, 2026
- EUDAMED cc72a723-34d7-41a1-bc7a-2ae2fe3a5c97 61 fields · synced Jul 8, 2026