AccessGUDID - DEVICE: CEKA & PRECI-LINE ATTACHMENTS (04260576941725)

GUDID

Device Identifier (DI) Information

Brand Name: CEKA & PRECI-LINE ATTACHMENTS
Version or Model: CEKA SITE B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CEKA SITE B
Company Name: Alphadent NV

Primary DI Number: 04260576941725
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 283174985 *Terms of Use

Device Description: CEKA SITE SET 2 x 2 GR

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
34782	Dentine bonding agent/set	A material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material; it may also be used as an enamel bonding material. It includes a resin-based bonding agent and may also include a primer, etching solution or curing activator, within the same formulation, or as part of a set. It is not a primer, etching solution and/or activator sold in the absence of a bonding agent; composite resin is not included. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EMB	ZINC OXIDE EUGENOL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Weight: 4 Gram
Device Size Text, specify: bonding composite

Device Record Status

Public Device Record Key: 80f85633-17b1-41dd-a040-1e64b9da109d
Public Version Date: February 16, 2024
Public Version Number: 2
DI Record Publish Date: March 30, 2021