Clearsplint

FDA UDI

Class U (US FDA UDI)

by Astron Dental

Identity

Trade Name: CLEARSPLINT FDA UDI
Generic Name: Custom-made mouthguard FDA UDI
Device Name: DENTURE MATERIAL - SUPER ECONO KIT - PACKAGE 960 GRAMS POWDER/ 3 EACH 240 GRAMS LIQUID FDA UDI
Model / Reference: PCSFSEK1 FDA UDI
Description: DENTURE MATERIAL - SUPER ECONO KIT - PACKAGE 960 GRAMS POWDER/ 3 EACH 240 GRAMS LIQUID FDA UDI

Identifiers

Catalog Number: PCSFSEK1 FDA UDI
Primary DI / UDI-DI: D810PCSFSEK11 FDA UDI
510(k) Number: K111828 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

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

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

Clearsplint by Astron Dental — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Custom-made mouthguard.

BENCO — BENCO DENTAL SUPPLY CO. · Class I
CORiTEC Splint Comfort — Pro3Dure Medical · U
SML — Selane Products, Inc. · U
Dentek — DenTek Oral Care, Inc. · U
PRO3DURE THERMEO Blank — Pro3Dure Medical · U
PRO3DURE THERMEO Powder — Pro3Dure Medical · U
BENCO — BENCO DENTAL SUPPLY CO. · Class I
SleepRight — Splintek, Inc. · U

Cleared under the same submission

K111828 also covers:

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

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Manufacturer

Manufacturer: Astron Dental

Sources (1)

FDA UDI 04f1c013-c401-4d9f-9c31-ffce2119da08 36 fields · synced May 31, 2026