OraPlace CR18417

by CranioMandibular Rehab, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00850056079198 UDI-DI	Date9 Sep 2026Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: OraPlace
Generic Name: Tongue/lip exerciser
Model / Reference: CR18417

Primary DI / UDI-DI: 00850056079198
FDA Product Code: EIF
GMDN Term: Tongue/lip exerciser

Device Class: Class I
Regulation Number: 872.4565
GUDID distribution status: In Commercial Distribution

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OraPlace CR18519

Class I
OraPlace CR18317

Class I

See all devices from CranioMandibular Rehab, Inc. →

Properties

Premarket Exempt
Lot / Batch Number
Manufacturing Date

Other properties (11)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Prescription Use: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Serial Number: No
Expiration Date: No