AccessGUDID - DEVICE: ASK (D798ASKU0)

GUDID

Device Identifier (DI) Information

Brand Name: ASK
Version or Model: ASKU
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ASKU
Company Name: RELIANCE ORTHODONTIC PRODUCTS INC

Primary DI Number: D798ASKU0
Issuing Agency: HIBCC
Commercial Distribution End Date: December 21, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 113170088 *Terms of Use

Device Description: The ASK Kit is intended for use to increase adhesion to normal, atypical (wet or dry) enamel surfaces (hypocalcified, fluorosed, deciduous enamel, dentin), sandblasted metal (amalgam, gold or stanless steel), porclain, zirconia, composite restorations and acrylic temporary/pontic teeth. The ASK kit contains the Etchmaster 4 Hole Handpiece adapter with both lingual and regular tips for microetching when required. The Unidose (single use) Assure Universal Bonding Resin included will bond to all intraoral surfaces, including zironia. Porcelain conditioner is provided for bonding to porcelain surfaces.

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:	Yes
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?
34782	Dentine bonding agent/set	A material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material; it may also be used as an enamel bonding material. It includes a resin-based bonding agent and may also include a primer, etching solution or curing activator, within the same formulation, or as part of a set. It is not a primer, etching solution and/or activator sold in the absence of a bonding agent; composite resin is not included. After application, this device cannot be reused.	Active	false
45403	Chairside dental abrasive air jet system	An assembly of devices that comprises a dental abrasive air jet system used to direct a concentrated jet of air combined with an abrasive powder, together with water for cooling, to the surface of the patient's tooth/teeth. It typically consists of a control unit, a dedicated intraoral handpiece and a foot switch that enables the dentist to control the abrasion process; some types are known as a sandblaster. It has a variety of applications such as, the removal of plaque and stains, cleaning fissures, the preparation of the tooth surface prior to bonding, the cleaning of orthodontic appliances (bands, brackets), the removal of adhesive residue and the cleaning of implants prior to loading.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KLE	Agent, Tooth Bonding, Resin
KOJ	Airbrush
DYH	Adhesive, Bracket And Tooth Conditioner, 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
Special Storage Condition, Specify: TEMPERATURE LIMITATION: Store at room temperature (15-30 degrees C). Protect from heat and light. Avoid evaporation.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 37f6b330-269a-4e5b-b06b-04d0182dcb9d
Public Version Date: July 03, 2026
Public Version Number: 4
DI Record Publish Date: July 25, 2016