BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

GC Tri Plaque ID Gel™

DI: D0470042731 · Model: 004273 · Gc America Inc.

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: GC Tri Plaque ID Gel™
Primary DI: D0470042731
Version / Model: 004273
Catalog Number: 004273
Company Name: Gc America Inc.
Labeler DUNS: 005473608
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-08-01
Public Version: 2
Public Version Date: 2018-03-29
Public Version Status: Update
Public Device Record Key: 6c322195-34b3-4301-8e8a-1a8379691ce2
Distribution End Date: 2016-08-06

Device Description

GC Tri Plaque ID Gel™ 40g tube (36 mL, approximately 130 applications)

Device Characteristics

Single Use: No
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: Yes
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: No
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NYH	plaque disclosing kit	Dental	872.1740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60408	Dental caries detecting stain	A liquid substance intended for use in dentistry as a staining agent to detect early stage dental caries and/or to monitor the progress of caries. It typically consists of two solutions (e.g., metal fluorides) that are applied separately to the suspect area of the tooth/teeth, and change colour in the presence of the caries-producing bacteria or bacterial residues, and/or remnants of the tooth structure from a carious lesion. The staining produced can be monitored over time to assess the progression/remission of the caries. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D0470042731	HIBCC

Customer Contacts

Phone: +1(708)597-0900
Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Weight	40	Gram

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: 8 – 25 Degrees Celsius