FDA.report

Caulk® Orthodontic Resin

Primary DI
D0026510111
Brand
Caulk® Orthodontic Resin
Company
DENTSPLY INTERNATIONAL INC.
Model
651011
Catalog number
651011
Device description
Caulk® Orthodonic Resin, Liquid, Clear, Regular Package
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EBIRESIN, DENTURE, RELINING, REPAIRING, REBASING

Product Code Classifications

CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D0026510111PrimaryHIBCC0

GMDN Terms

TermDefinition
Temporary dental crown/bridgeA prosthetic dental device intended to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].

Device Sizes

TypeValueUnit
Device Size Text, specify0
Total Volume430Milliliter
Weight605Gram

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
083235549
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
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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