AccessGUDID - DEVICE: CERAMILL PEEK by JUVORA™ (05055948228639)

GUDID

Device Identifier (DI) Information

Brand Name: CERAMILL PEEK by JUVORA™
Version or Model: 760401
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: JUVORA LIMITED

Primary DI Number: 05055948228639
Issuing Agency: GS1
Commercial Distribution End Date: March 02, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 218501322 *Terms of Use

Device Description: CERAMILL PEEK by JUVORA™ 760401, Natural 98 x 12/US – 1 unit

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
58288	Dental appliance fabrication material, thermoplastic	A thermoplastic material intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture/denture base, orthodontic retainer, implant bars, crowns/bridges, occlusal splint, mouthguard); it might in addition be intended to fabricate non-patient worn devices (e.g., dental impression tray). The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank, thermoplastic sheet] is manipulated [e.g., by melting and moulding, or computer-aided techniques (dental CAD/CAM)] to form the shape needed for the patient. After application, this material cannot be refabricated.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBF	Material, Tooth Shade, Resin
EBG	Crown And Bridge, Temporary, Resin
EBI	Resin, Denture, Relining, Repairing, Rebasing

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K132725	000
K160918	000

Device Exempt from Premarket Submission: No 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
Height: 12 Millimeter
Outer Diameter: 98 Millimeter

Device Record Status

Public Device Record Key: 6ae11e41-2912-4f1d-b288-b94930744c38
Public Version Date: June 21, 2022
Public Version Number: 4
DI Record Publish Date: January 24, 2018