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The Original Clearsplint Disc

FDA UDI

Class U (US FDA UDI)

by Astron Dental

Identity

Trade Name
The Original Clearsplint Disc FDA UDI
Generic Name
Mouthguard, single-use FDA UDI
Device Name
Package of 1 disc 95mmX20mm Zirkonzahn/Clover Leaf Edge FDA UDI
Model / Reference
PCSD95 FDA UDI
Description
Package of 1 disc 95mmX20mm Zirkonzahn/Clover Leaf Edge FDA UDI

Identifiers

Catalog Number
PCSD95 FDA UDI
Primary DI / UDI-DI
D810PCSD2095Z111 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

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: Mouthguard, single-use

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

Similar devices

Also classified as Mouthguard, single-use.

Cleared under the same submission

K111828 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Astron Dental

Sources (1)

  • FDA UDI 7177e2f1-9fc6-4806-8a97-2079c3c6767e 36 fields · synced May 30, 2026