AccessGUDID - DEVICE: Calibra® Universal+ Versatile Resin Cement (D002607400NA1)

GUDID

Device Identifier (DI) Information

Brand Name: Calibra® Universal+ Versatile Resin Cement
Version or Model: 607400NA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 607400NA
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D002607400NA1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Calibra® Universal+ Syringe Introductory 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?
35870	Dental composite resin	A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EMA	CEMENT, DENTAL

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 2 and 24 Degrees Celsius
Special Storage Condition, Specify: Do not freeze.
Special Storage Condition, Specify: Use the product at room temperature.
Special Storage Condition, Specify: Do not use after expiration date.
Special Storage Condition, Specify: Keep out of direct sunlight.
Special Storage Condition, Specify: Protect from moisture.
Special Storage Condition, Specify: Do not use if lot number and/or expiration date are missing or illegible.
Special Storage Condition, Specify: Store in a well-ventilated place.
Special Storage Condition, Specify: Allow material to reach room temperature prior to use.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 5 Syringes (4.5g each), 1 in each shade (Light, Medium, Translucent, Opaque, Bleach); 50 Mixing Tips

Device Record Status

Public Device Record Key: 911a504d-301b-4c50-9b1c-ee9dd6544f93
Public Version Date: May 27, 2024
Public Version Number: 1
DI Record Publish Date: May 17, 2024