AccessGUDID - DEVICE: Tylok® Plus Anhydrous Polycarboxylate Cement (D0026202010)

GUDID

Device Identifier (DI) Information

Brand Name: Tylok® Plus Anhydrous Polycarboxylate Cement
Version or Model: 620201
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 620201
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D0026202010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Tylok® Plus Anhydrous Polycarboxylate Cement, Powder, 1 (50g) bottle Refill

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:	No
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?
16705	Zinc polycarboxylate dental cement	A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between zinc oxide (ZnO) and aqueous solutions of polycarboxylic acid (e.g., polyacrylic acid). It typically includes some additional fillers/components. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EMA	CEMENT, DENTAL

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
Special Storage Condition, Specify: Keep away from sunlight. Keep dry.
Storage Environment Temperature: between 10 and 24 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 1 Powder (50g) 1 Powder Scoop
Weight: 50 Gram

Device Record Status

Public Device Record Key: 56123026-edf0-4e41-9aa8-6eaa8d35f104
Public Version Date: December 12, 2022
Public Version Number: 4
DI Record Publish Date: September 21, 2016