Jet Set-4 Tooth Shade Powder 250 Gram Shade Medium

by Lang Dental Manufacturing Company, Inc. 2 variants

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	NumberD65038H0MED UDI-DI	Date10 Feb 2017Listed	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Withdrawn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: Jet Set-4 Tooth Shade Powder
Generic Name: Temporary dental crown/bridge resin
Model / Ref / Catalog: 250 GRAM SHADE MEDIUM, 38H0MED

Primary DI / UDI-DI: D65038H0MED
510(k) Number: K083195
FDA Product Code: EBG
GMDN Term: Temporary dental crown/bridge resin

Device Class: Class II
Regulation Number: 872.3770
GUDID distribution status: In Commercial Distribution

From the manufacturer

Manufacturer's product page: Jet Set-4™

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Class II
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Class II
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Class II
Jet Denture Repair Powder

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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