Ortho-Jet Crystal Powder 100 Gram

by Lang Dental Manufacturing Company, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 22 Oct 2026

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	NumberD6500220C0 UDI-DI	Date1 Sep 2016Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Ortho-Jet Crystal Powder
Generic Name: Dental prosthesis restorative material, unfilled resin
Model / Ref / Catalog: 100 GRAM, 0220C

Primary DI / UDI-DI: D6500220C0
510(k) Number: K112397
FDA Product Code: EBI
GMDN Term: Dental prosthesis restorative material, unfilled resin

Device Class: Class II
Regulation Number: 872.3760
GUDID distribution status: In Commercial Distribution

From the manufacturer

Manufacturer's product page: Ortho-Jet Crystal

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Properties

Single Use
Prescription Use
Lot / Batch Number
Expiration Date

Other properties (10)

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