Symmetry Facial Plane Relator Introductory Kit

Basic Information

• Brand Name: Symmetry Facial Plane Relator Introductory Kit
• Primary DI: 07540172001014
• Version / Model: 051940
• Catalog Number: 051940
• Company Name: CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
• Labeler DUNS: 626406016
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-22
• Public Version: 1
• Public Version Date: 2020-10-30
• Public Version Status: New
• Public Device Record Key: 2e1f4e09-e40a-4413-aee0-5789114c3cd5

Device Description

Bite registration rim

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
ELW	MATERIAL, IMPRESSION	Dental	872.3660	2
EID	SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL	Dental	872.4565	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	07540172001014	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature
• Type: Storage Environment Temperature
• Temperature Range: High: 25 Degrees Celsius