OneBite Evolution

Basic Information

• Brand Name: OneBite Evolution
• Primary DI: 00850031761834
• Version / Model: OBEV0115
• Catalog Number: OBEV0115
• Company Name: Precision Dental Products LLC
• Labeler DUNS: 081523806
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-07
• Public Version: 1
• Public Version Date: 2022-04-15
• Public Version Status: New
• Public Device Record Key: 7b53157a-da4d-4bdf-bfa9-6c7c9fc75680

Device Description

Dental Technician Magnetic Record Kit - 10

Device Characteristics

• Single Use: Yes
• 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: Yes
• PM Exempt: Yes
• 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
EHY	Tray, Impression, Preformed	Dental	872.6880	1

GMDN Terms

Code	Name	Definition	Implantable	Status
18083	Bite registration rim	A schematic model of the dental arch attached to a temporary or permanent base for recording jaw relationships. Bite rims can be individually made or adjusted to one patient from preformed devices. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850031761834	GS1

Customer Contacts

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