CORiTEC Splint Comfort

FDA UDI

Class U (US FDA UDI)

by Pro3Dure Medical

Identity

Trade Name: CORiTEC Splint Comfort FDA UDI
Generic Name: Custom-made mouthguard FDA UDI
Device Name: CORiTEC disc, diameter 98.5 mm, height 20 mm FDA UDI
Model / Reference: clear transparent, height 20 mm FDA UDI
Description: CORiTEC disc, diameter 98.5 mm, height 20 mm FDA UDI

Identifiers

Catalog Number: PEMCR00020 FDA UDI
Primary DI / UDI-DI: 01111111111123 FDA UDI
510(k) Number: K212017 FDA UDI
FDA Product Code: MQC FDA UDI
GMDN Term: Custom-made mouthguard FDA UDI

Classification

Device Class: U FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Custom-made mouthguard

CORiTEC Splint Comfort by Pro3Dure Medical — Class U — FDA UDI — listed in FDA GUDID — 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

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 U	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Pro3Dure Medical

Sources (1)

FDA UDI 8b697e36-fa65-4c58-ada1-21f5012332af 36 fields · synced May 30, 2026