FDA.report

Comspan® Composite Luting Cement

Primary DI
D0029552501
Brand
Comspan® Composite Luting Cement
Company
DENTSPLY INTERNATIONAL INC.
Model
955250
Catalog number
955250
Device description
Comspan Composite Luting Cement Opaque Base
Published
2019-04-02
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

Product Codes

CodeName
EBHMATERIAL, IMPRESSION TRAY, RESIN

Product Code Classifications

CodeDeviceSpecialtyClass
EBHMaterial, Impression Tray, ResinDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D0029552501PrimaryHIBCC0

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
Weight5Gram

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)532-2855MilfordDE-Customer-Service@den

Regulatory Flags

DUNS number
083235549
Device count
1
DM exempt
false
Premarket exempt
true
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
false
Sterilization required before use
false

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