AccessGUDID - DEVICE: ALPHA-DENT® Glass Ionomer Cement (D73530700000010)

GUDID

Device Identifier (DI) Information

Brand Name: ALPHA-DENT® Glass Ionomer Cement
Version or Model: 307.0000.001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 307.0000.001
Company Name: DENTAL TECHNOLOGIES, INC.

Primary DI Number: D73530700000010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 148312838 *Terms of Use

Device Description: ALPHA-DENT® Glass Ionomer Cement is specially formulated for superior strength, resistance to dissolution, and oral retention. They are impervious to oral fluids, and thus permanent under oral conditions. The material is recommended for cementing crowns, inlays, orthodontic bands, temporary fillings, fixed bridges, or as a base under any filling material. Kit Contains: 18g Powder, 16.5ml Liquid, Measuring Scoop, Mixing Pad

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?
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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K935436	000

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
Storage Environment Temperature: between 2 and 27 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8a2f57d1-d4c4-4b2f-ab55-0e07fcba868d
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016