CEKA & PRECI-LINE ATTACHMENTS

Basic Information

• Brand Name: CEKA & PRECI-LINE ATTACHMENTS
• Primary DI: 04260576941565
• Version / Model: 691 E
• Catalog Number: 691 E
• 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: 4903a681-0e52-44f6-9088-df5d49f024c6

Device Description

CEKA M3 LARGE SP. MAINT. 0.4MM 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
EGG	ATTACHMENT, PRECISION, ALL	Dental	872.3165	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38603	Resilient dental precision attachment	A dental fixation device designed to give a tooth-borne/tissue-borne prosthesis sufficient mechanical play to withstand the variations in the seating of the prosthesis due to deformation of the underlying tissues, without placing excessive stress on the abutments.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260576941565	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			M3 size space maintainer
Lumen/Inner Diameter	3	Millimeter