AccessGUDID - DEVICE: Ketac™ Cem Maxicap™ (J001702011033580)

GUDID

Device Identifier (DI) Information

Brand Name: Ketac™ Cem Maxicap™
Version or Model: 56015
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 56015
Company Name: 3M Deutschland GmbH

Primary DI Number: J001702011033580
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 315731711 *Terms of Use

Device Description: 3M™ ESPE™ Ketac™ Cem Maxicap™ Glass Ionomer Luting Cement Introductory Kit, 56015

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60885	Dental material cartridge-plunging applicator, two-component, manual	A hand-held manual device intended to dispense a two-component dental material (e.g., impression material) [not included] from a cartridge directly into the mouth or into another device (e.g., impression tray). It is typically a pistol-like device with a cartridge-plunging mechanism; typically, a dental material mixing nozzle is attached to the distal tip of the cartridge during use. This is a reusable device after appropriate cleaning.	Active	false
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
EID	SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL

FDA Premarket Submission

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

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

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1444df26-eb55-492e-a45e-49281f9bff7b
Public Version Date: January 08, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016