AccessGUDID - DEVICE: GC Fuji II LC® (D6584250201)

GUDID

Device Identifier (DI) Information

Brand Name: GC Fuji II LC®
Version or Model: 425020
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 425020
Company Name: Gc America Inc.

Primary DI Number: D6584250201
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 24
Labeler D-U-N-S® Number*: 005473608 *Terms of Use

Device Description: GC Fuji II LC® Dark Shades, Quantity of 24 capsules (5 each of A3.5, A4, B3 and B4 shades; 4 each of C4 shades; 0.33g powder; 0.085mL liquid per capsule).

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Glass ionomer dental cement	A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). After application, this device cannot be reused.

GMDN Preferred Term Name

GMDN Definition

Glass ionomer dental cement

A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). After application, this device cannot be reused.

FDA Product Code

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Product Code	Product Code Name
EMA	CEMENT, DENTAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K993973	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 4 and 25 Degrees Celsius
Storage Environment Temperature: between 39 and 77 Degrees Fahrenheit

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d89ced69-dadb-4328-a048-f181efae13eb
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 01, 2016