AccessGUDID - DEVICE: Alpha-Seal® (D73540101030020)

GUDID

Device Identifier (DI) Information

Brand Name: Alpha-Seal®
Version or Model: 401.0103.002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 401.0103.002
Company Name: DENTAL TECHNOLOGIES, INC.

Primary DI Number: D73540101030020
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 148312838 *Terms of Use

Device Description: Alpha-Seal® is a light cure resin-based Pit & Fissure Sealant with fluoride. This sealant contains 50% radiopaque nano-sized fillers. The hard setting, wear resistant material has an ideal flowable viscosity for maximum coverage and protection to seal the pits and fissures of teeth suseptible to caries. The syringe needle tips allow for quick and accurate placement of the material. Alpha-Seal® is available in Opaque shade to allow for easy identification during patient examinations and in a Clear shade for patients who wish to have an "invisible" sealant. Kit Contains: 1 x 1.5g Sealant Syringe (Opaque White), 3 Dispensing Tips

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?
31780	Dental pit/fissure sealant	A resin-based dental material suitable for sealing pits and fissures on teeth. It may be chemically cured or external energy cured. After application, this device cannot be reused.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EBC	Sealant, Pit And Fissure, And Conditioner

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K924635	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: 51ec993f-7db7-4639-89a5-37d90cf33566
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016