Identity
- Trade Name
- E-Guard FDA UDI
- Generic Name
- Removable dental occlusal splint, custom-made FDA UDI
- Device Name
- E-Guard is a light-curing material for the additive manufacturing of individual dental bite splints. FDA UDI
- Model / Reference
- RES-01-3113 FDA UDI
- Description
- E-Guard is a light-curing material for the additive manufacturing of individual dental bite splints. FDA UDI
Identifiers
- Catalog Number
- RES-01-3113 FDA UDI
- Primary DI / UDI-DI
- 04260683220102 FDA UDI
- 510(k) Number
- K201173 FDA UDI
- FDA Product Code
- MQC FDA UDI
- GMDN Term
- Removable dental occlusal splint, custom-made FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
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: Removable dental occlusal splint, custom-madeCustom-made mouthguard
E-Guard by Envisiontec GmbH — Class U — MDR, MDD, 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
- CORiTEC Splint Comfort — Pro3Dure Medical · U
- SML — Selane Products, Inc. · U
- Dentek — DenTek Oral Care, Inc. · U
- ASTRON LC — Astron Dental · Class II
- PRO3DURE THERMEO Blank — Pro3Dure Medical · U
- PRO3DURE THERMEO Powder — Pro3Dure Medical · U
Cleared under the same submission
K201173 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class U | Unknown |
| EUDAMED | European Union | MDD | — | Class U | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Envisiontec GmbH
Sources (2)
- FDA UDI f21b4604-b699-4fb1-90fd-49ce9f1bbcaf 37 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026