CEKA & PRECI-LINE ATTACHMENTS

Basic Information

• Brand Name: CEKA & PRECI-LINE ATTACHMENTS
• Primary DI: 04260576941855
• Version / Model: H 35
• Catalog Number: H 35
• Company Name: Alphadent NV
• Labeler DUNS: 283174985
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-30
• Public Version: 1
• Public Version Date: 2021-04-07
• Public Version Status: New
• Public Device Record Key: df0f962b-af17-4543-bde5-ab6c979710a2

Device Description

CKPL MEASURING GAUGE 1 P.

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: MR Safe
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
EJB	HANDLE, INSTRUMENT, DENTAL	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45240	Interproximal/occlusal dental gauge, single-use	A device intended to be used to directly measure the interproximal (adjacent) and/or occlusal (opposing) clearance of a prepared tooth, typically to ensure sufficient space in the development of a dental restoration. The device may be in the form of a flexible tab (e.g., thermoplastic material) available in a variety of standard thicknesses. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260576941855	GS1

Customer Contacts

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