NeoCrystal 714-399SBI

by Ortho Organizers, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 23 Oct 2026

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	Number00190707003357 UDI-DI	Date24 Sep 2016Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: NeoCrystal
Generic Name: Orthodontic bracket, ceramic
Model / Reference: 714-399SBI

Primary DI / UDI-DI: 00190707003357
510(k) Number: K110335
FDA Product Code: NJM
GMDN Term: Orthodontic bracket, ceramic

Device Class: Class II
Regulation Number: 872.5470
GUDID distribution status: In Commercial Distribution

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Properties

Single Use
Prescription Use
Convenience Kit
Lot / Batch Number

Other properties (10)

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