AccessGUDID - DEVICE: Alphaseal Liner (D83610211)

GUDID

Device Identifier (DI) Information

Brand Name: Alphaseal Liner
Version or Model: 1021
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1021
Company Name: DENT ZAR, INC.

Primary DI Number: D83610211
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 789664455 *Terms of Use

Device Description: Alphaseal is a visible light cured cavity liner. It has a light paste consistency to facilitate the application. OUTSTANDING FEATURES OF THE PRODUCT: • Fast and easy to apply • Economical • Compatible with all restoratives and cements • Mechanically strong and insoluble in oral fluids • Long shelf-life; no refrigeration required • Resistant to etching agents • X-ray opaque • Simplified handling; direct to tooth application

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":	Yes
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?
62199	Calcium hydroxide dental cement	A non-sterile, non-aqueous substance intended for professional use as a dental cement (e.g., pulp capping, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between calcium hydroxide and salicylic acid (or related esters such as butan-1,3-diol disalicylate). It typically includes some additional fillers/components. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBF	Material, Tooth Shade, Resin

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: dcf583a2-dffd-40c5-84b5-9663d50ccbbe
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 04, 2016