AccessGUDID - DEVICE: CEREC® Essentials with Celtra® Duo (ZLS) Blocks (D00261N0021)

GUDID

Device Identifier (DI) Information

Brand Name: CEREC® Essentials with Celtra® Duo (ZLS) Blocks
Version or Model: 61N002
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 61N002
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D00261N0021
Issuing Agency: HIBCC
Commercial Distribution End Date: June 05, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: CEREC® Essentials with Celtra® Chairside Consumables Kit

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

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

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 12 Blocks, 3 Firing Pads, 1 Syr. Calibra Ceram w/10 mix tips, 1 bottle Prime&Bond elect, 25 flocked app. tips, 1 disp. well, 1 syr. Coupling Agent w/25 disp. app. needles, 1 Stain & Glaze Kit

Device Record Status

Public Device Record Key: b913575a-a813-45ee-bc5b-6cfc37c3c007
Public Version Date: June 05, 2024
Public Version Number: 2
DI Record Publish Date: May 26, 2022