A-dec

Basic Information

• Brand Name: A-dec
• Primary DI: 10194665002961
• Version / Model: 11.0232.80
• Company Name: A-DEC, INC.
• Labeler DUNS: 009617473
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-18
• Public Version: 1
• Public Version Date: 2022-05-26
• Public Version Status: New
• Public Device Record Key: 0e4ac014-5924-408b-8ab2-5dd24a6909f3

Device Description

Tooth Dryer ASSY

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EIA	Unit, Operative Dental	Dental	872.6640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45116	Tooth dryer	A device used in general and orthodontic dentistry to dry the surface of a tooth undergoing treatment prior to the application of dental products (e.g., adhesives, composites, sealants). The device provides pure warm air (free from contaminants) directly to the site of intervention, and is typically designed like a dental handpiece so that the operator can access any tooth within the oral cavity. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10194665002961	GS1

Premarket Submissions

Submission Number	Supplement Number
K000968	000