AccessGUDID - DEVICE: CHEMFIL ROCK (D010606065901)

GUDID

Device Identifier (DI) Information

Brand Name: CHEMFIL ROCK
Version or Model: 60606590
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 60606590
Company Name: Dentsply De Trey GmbH

Primary DI Number: D010606065901
Issuing Agency: HIBCC
Commercial Distribution End Date: December 31, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 315471722 *Terms of Use

Device Description: CHEMFIL ROCK INTRO KIT is a high-strength zinc-reinforced glass ionomer restorative in capsule delivery that can be bulk placed and is self cure setting. The capsule extruder is used for the extrusion and direct application of the capsules. With its supporting accessory (Capsule Extruder) it can be classified as a convenience kit.

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):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
16704	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBF	MATERIAL, TOOTH SHADE, RESIN
EMA	CEMENT, DENTAL
EBC	SEALANT, PIT AND FISSURE, AND CONDITIONER
EJK	LINER, CAVITY, CALCIUM HYDROXIDE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Weight: 442 Milligram
Total Volume: 0.12 Milliliter
Device Size Text, specify: Powder
Device Size Text, specify: Liquid

Device Record Status

Public Device Record Key: bc340f6d-c80f-437e-bb73-a3e8c064f968
Public Version Date: January 05, 2023
Public Version Number: 3
DI Record Publish Date: September 20, 2016