Aseptico

Basic Information

• Brand Name: Aseptico
• Primary DI: 10817417022306
• Version / Model: AEU-350
• Catalog Number: AEU-350
• Company Name: ASEPTICO, INC.
• Labeler DUNS: 016853348
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-31
• Public Version: 1
• Public Version Date: 2021-09-08
• Public Version Status: New
• Public Device Record Key: 6edf2f4e-1f5b-46fc-b507-2b86ee2cb307
• Distribution End Date: 2030-07-31

Device Description

AEU-350 Portable Dentistry System

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

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

GMDN Terms

Code	Name	Definition	Implantable	Status
34991	Dental delivery system	A stationary, mains electricity (AC-powered) device assembly designed to provide dental staff with the necessary utilities/amenities to deliver dental treatment to a patient. The utilities/amenities are typically compressed air, water, suction, electricity, table top or bracket table surfaces, cuspidor, gas, and sometimes the dental light. This is a fixed-position system (i.e., not mobile) which incorporates an instrument unit for dental instrument provision. The patient examination/treatment chair is typically integrated as part of this system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10817417022306	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K130693	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Humidity
• Temperature Range: 10 – 28 Degrees Celsius