ScanBox pro - Candid

Basic Information

• Brand Name: ScanBox pro - Candid
• Primary DI: 03770021392916
• Version / Model: 001
• Catalog Number: 1011-001
• Company Name: DENTAL MONITORING
• Labeler DUNS: 269129881
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-16
• Public Version: 1
• Public Version Date: 2024-09-24
• Public Version Status: New
• Public Device Record Key: cc7d08cb-e130-49ca-8e5a-2c17f94e2c10

Device Description

Phone support + Cheek retractor ScanBoxpro L Pack. The kit contains 3 elements: -1 Cheek Retractor: Large size (L). -1 Adaptor -1 Phone support.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: 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
EIG	Retractor, All Types	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44828	Dental cheek retractor, professional, reusable	A hands-free, self-retaining frame intended to allow a dental professional to retract the lips/cheeks of a patient during an orthodontic or restorative dental procedure for easy access to the field of operation. It is designed to be placed in and around the lips/cheeks and may also be designed to displace the tongue. It is a synthetic polymer device which may include suction adaptors/tubing for saliva removal to maintain a dry field. It is not intended to be placed between the teeth (i.e., not a mouth gag). This is a reusable device.	No	Active
63817	Dental cheek retractor, home-use	A hands-free, self-retaining frame intended to be used in the home by a patient to retract the lips/cheeks to facilitate viewing of the teeth (e.g., to allow photographs to be taken and sent to a healthcare professional). It is a synthetic polymer device designed to be placed in and around the lips/cheeks; it is not intended to be placed between the teeth (i.e., not a mouth gag). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	03770021392923	GS1	Shipping carton	50	In Commercial Distribution
Primary	03770021392916	GS1
Direct Marking	03770021392039	GS1

Customer Contacts

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