AccessGUDID - DEVICE: CHEMFIL ROCK (D010606065911)

GUDID

Device Identifier (DI) Information

Brand Name: CHEMFIL ROCK
Version or Model: 60606591
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 60606591
Company Name: Dentsply De Trey GmbH

Primary DI Number: D010606065911
Issuing Agency: HIBCC
Commercial Distribution End Date: December 31, 2022
Device Count: 50
Labeler D-U-N-S® Number*: 315471722 *Terms of Use

Device Description: CHEMFIL ROCK A1 REFILL is a high-strength zinc-reinforced glass ionomer restorative in capsule delivery that can be bulk placed and is self cure setting.

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:	No
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
EMA	CEMENT, DENTAL
EBF	MATERIAL, TOOTH SHADE, RESIN
EJK	LINER, CAVITY, CALCIUM HYDROXIDE
EBC	SEALANT, PIT AND FISSURE, AND CONDITIONER

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

Device Record Status

Public Device Record Key: 6c261840-981a-482a-8a88-1678c308ee10
Public Version Date: January 05, 2023
Public Version Number: 3
DI Record Publish Date: September 20, 2016