Who else makes this device?

Name: GingaGuard
Brand: GingaGuard

Dental › ProstheticCoating, Filling Material, Resin

GingaGuard

Catalogue number 902101, listed by Cosmedent, Inc., United States, under Coating, Filling Material, Resin. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

3510(k) clearances naming this product code

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code EBD
Manufacturer	City	Province	Registered as	Device types
Yamahachi Dental Material (Changshu) Co., Ltd.	Changshu	Jiangsu	Manufacturer	9

Record

Regulatory record for GingaGuard
Listed by	Cosmedent, Inc., United States
FDA product code	EBD
Device type	Coating, Filling Material, Resin
Device class	Class 2
Regulation	21 CFR 872.3310
Establishment	Repacker / relabeller
510(k)	K011239
Record published	2016-09-22
Record revised	2018-07-06 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for GingaGuard
Catalogue number	Size	Status
902101		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
ID Lightcure System	ID Korea Co., Ltd.	63
Minute Stain	Taub Products	56
Optiglaze™	GC America Inc.	44
Rodin	PAC-Dent Inc.	39
Renamel® Flowable Microfill	Deltamed Gmbh	27
Vita Akzent® LC	Vita – Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft	27
Renamel® Flowable Microfill	Cosmedent, Inc.	26
Radica®	Dentsply LLC	20
SciPharm Support Self Cured Core Build-Up Restorative Reverse	Scientific Pharmaceuticals, Inc.	18
Renamel® Flowable Microhybrid	Cosmedent, Inc.	16
Glaze	Taub Products	14
Signum matrix	Kulzer SRL	14

Showing 12 of 100. All products under Coating, Filling Material, Resin

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K011239	2002-02-14
K980298	1998-03-09
K974494	1998-02-10

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.