Caulk® Compules® Tips Gun

Primary DI
D0026351051
Brand
Caulk® Compules® Tips Gun
Company
DENTSPLY INTERNATIONAL INC.
Model
635105
Catalog number
635105
Device description
Caulk® Compules® Tips Gun
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBFMATERIAL, TOOTH SHADE, RESIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D0026351051PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental material cartridge-plunging applicator, single-componentA hand-held manual device intended to dispense a single-component dental material (not included) from a cartridge directly into the mouth; it is not intended to dispense more than one component simultaneously. It is typically a pistol-like device with a cartridge-plunging mechanism. This is a reusable device after appropriate cleaning.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
083235549
Device count
1
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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D0013010481Ceramco® 3Paste Opaque A3.53010482016-09-21
D0013010591Ceramco® 3Paste Opaque C23010592016-09-21
D0013010701Ceramco® 3Paste Opaque Modifiers White3010702016-09-21
D0013011031Ceramco® 3Opaceous Dentin i13011032016-09-21
D0013011071Ceramco® 3Opaceous Dentin A3.53011072016-09-21
D0013011101Ceramco® 3Opaceous Dentin i63011102016-09-21
D0013011181Ceramco® 3Opaceous Dentin C23011182016-09-21
D0013011221Ceramco® 3Opaceous Dentin D33011222016-09-21
D0013011501Ceramco® 3Dentin C43011502016-09-21
D0013011611Ceramco® 3Dentin Modifier A3.53011612016-09-21
D0013011671Ceramco® 3Dentin Modifier Blue3011672016-09-21
D0013012001Ceramco® 3Natural Enamel White3012002016-09-21
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D0013013221Ceramco® 3Overglaze3013222016-09-21

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