Clearsplint

FDA UDI

Class U (US FDA UDI)

by Astron Dental

Identity

Trade Name: CLEARSPLINT FDA UDI
Generic Name: Mouthguard, single-use FDA UDI
Device Name: Clearsplint Disc 95mm x 16mm Clover Edge Clear 1 Unit FDA UDI
Model / Reference: PCSD1695Z1 FDA UDI
Description: Clearsplint Disc 95mm x 16mm Clover Edge Clear 1 Unit FDA UDI

Identifiers

Catalog Number: PCSD1695Z1 FDA UDI
Primary DI / UDI-DI: D810PCSD1695Z111 FDA UDI
510(k) Number: K111828 FDA UDI
FDA Product Code: MQC FDA UDI
GMDN Term: Mouthguard, single-use FDA UDI

Classification

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

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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: Mouthguard, single-use

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

Similar devices

Also classified as Mouthguard, single-use.

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Sharn Inc — Sharn Anesthesia · Class I
Toothette Oral Care — SAGE PRODUCTS LLC · Class I
Bioseal Inc. — BIOSEAL · Class I
SunMed — SunMed · Class I
Bioseal Inc. — BIOSEAL · Class I

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 c6a73dbf-776a-477e-bd06-84d1a71a1b4d 36 fields · synced May 30, 2026