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The Slide®

FDA UDI

Class II (US FDA UDI)

by Biotex, Inc.

Identity

Trade Name
The Slide® FDA UDI
Generic Name
Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
Device Name
Slide Nylon. FDA UDI
Model / Reference
046-1500 FDA UDI
Description
Slide Nylon. FDA UDI

Identifiers

Primary DI / UDI-DI
M71004615000 FDA UDI
510(k) Number
K203712 FDA UDI
FDA Product Code
LQZ FDA UDI
LRK FDA UDI
GMDN Term
Mandible-repositioning sleep-disordered breathing orthosis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.5570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Mandible-repositioning sleep-disordered breathing orthosis

The Slide® by Biotex, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mandible-repositioning sleep-disordered breathing orthosis.

Cleared under the same submission

K203712 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biotex, Inc.

Sources (1)

  • FDA UDI 513f905f-5ecd-40f4-839e-5a982cd01580 36 fields · synced May 29, 2026