RS VIVO Splint Flex 1000g 04723

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberEDET047231 UDI-DI	Date20 Nov 2025Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: RS VIVO Splint Flex 1000g
Generic Name: Removable dental occlusal splint, custom-made
Model / Reference: 04723

Primary DI / UDI-DI: EDET047231
FDA Product Code: DYJ, KMY, MQC
GMDN Term: Removable dental occlusal splint, custom-made

Device Class: Class I
Regulation Number: 872.5410, 872.5525
GUDID distribution status: In Commercial Distribution

MRI Safety: MR Safe

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Properties

Single Use
Lot / Batch Number
Expiration Date

Other properties (11)

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