FDA.report

Calibra® Universal+ Versatile Resin Cement

Primary DI
D002607405NA0
Brand
Calibra® Universal+ Versatile Resin Cement
Company
DENTSPLY INTERNATIONAL INC.
Model
607405NA
Catalog number
607405NA
Device description
Calibra® Universal+ Syringe Refill - Translucent Shade
Published
2024-05-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EMACEMENT, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EMACement, DentalDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D002607405NA1PrimaryHIBCC0
D002607405NA0Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental composite resinA 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.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Allow material to reach room temperature prior to use.
Special Storage Condition, Specify00Do not freeze.
Special Storage Condition, Specify00Do not use after expiration date.
Special Storage Condition, Specify00Do not use if the lot number and/or expiration date are missing or illegible.
Special Storage Condition, Specify00Keep out of direct sunlight.
Special Storage Condition, Specify00Protect from moisture.
Special Storage Condition, Specify00Store in a well-ventilated place.
Special Storage Condition, Specify00Use the product at room temperature.
Storage Environment Temperature2 Degrees Celsius24 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)532-2855MilfordDE-Customer-Service@dentsplysirona.com

Regulatory Flags

DUNS number
083235549
Device count
2
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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