AccessGUDID - DEVICE: CEREC® Essentials with Celtra® Duo (ZLS) Blocks (D0026071031)

GUDID

Device Identifier (DI) Information

Brand Name: CEREC® Essentials with Celtra® Duo (ZLS) Blocks
Version or Model: 607103
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 607103
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D0026071031
Issuing Agency: HIBCC
Commercial Distribution End Date: March 01, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: CEREC® Essentials Combo Kit with Celtra® Duo (ZLS) Blocks

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
16187	Dental appliance fabrication material, ceramic	A dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EMA	CEMENT, DENTAL
EIH	POWDER, PORCELAIN
KLE	AGENT, TOOTH BONDING, RESIN

FDA Premarket Submission

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

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
Special Storage Condition, Specify: Keep away from direct sunlight.
Special Storage Condition, Specify: Protect from moisture.
Storage Environment Temperature: between 10 and 24 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 4 blocks, 3 Firing Pads, 1 Syringe Coupling Agent, 1 Overglaze, 1 Stain & Glaze Liquid, 1 Calibra Ceram Syringe, 10 mix tips, 1 mixing well, 1 bottle Prime&Bond elect, 25 flocked applicator tips

Device Record Status

Public Device Record Key: 3418ccc2-14c5-4073-8430-8c574a7411cc
Public Version Date: March 02, 2023
Public Version Number: 2
DI Record Publish Date: May 25, 2022