FDA.reportPublic FDA data

CAMouflage

Primary DI
D745701000CMN00331
Brand
CAMouflage
Company
Prismatik Dentalcraft, Inc
Model
70-1000-CMN0033
Catalog number
70-1000-CMN0033
Device description
CAMouflage NOW Milling Blocks; GD-Mandrel; A2 LT; 14 (5 units)
Published
2018-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBFMATERIAL, TOOTH SHADE, RESIN

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160425000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160425000CAD/CAMouflage Milling BockPrismatik Dentalcraft, Inc.2016-07-15EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D745701000CMN00331PrimaryHIBCC0
D745701000CMN00330Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made dental composite resin kitA collection of customized equipment and supplies intended to be used to apply/polymerize composite resins to fill dental cavities or restore damaged dental tissue. It includes the composite resin, which may be self-, light-, or dual-cured, and additional devices which typically include a dental syringe, a mixing palette, a mixing pad, and brushes; it is customized for a specific patient. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)854-7256xx@xx.xx

Regulatory Flags#

DUNS number
022761689
Device count
5
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D745701204GLG00011Glidewell™70-1204-GLG000170-1204-GLG00012026-04-15
D745701204GLG00021Glidewell™70-1204-GLG000270-1204-GLG00022026-04-15
D745701204GLG00031Glidewell™70-1204-GLG000370-1204-GLG00032026-04-15
D745701204GLG00041Glidewell™70-1204-GLG000470-1204-GLG00042026-04-15
D745701204GLG00051Glidewell™70-1204-GLG000570-1204-GLG00052026-04-15
D745701190PRA00650Glidewell HT™70-1190-PRA006570-1190-PRA00652025-03-10
D745701190PRA00660Glidewell HT™70-1190-PRA006670-1190-PRA00662025-03-10
D745701190PRA00670Glidewell HT™70-1190-PRA006770-1190-PRA00672025-03-10
D745701190PRA00680Glidewell HT™70-1190-PRA006870-1190-PRA00682025-03-10
D745701190PRA00690Glidewell HT™70-1190-PRA006970-1190-PRA00692025-03-10
D745701190PRA00010Glidewell HT™70-1190-PRA000170-1190-PRA00012024-03-21
D745701190PRA00020Glidewell HT™70-1190-PRA000270-1190-PRA00022024-03-21
D745701190PRA00030Glidewell HT™70-1190-PRA000370-1190-PRA00032024-03-21
D745701190PRA00040Glidewell HT™70-1190-PRA000470-1190-PRA00042024-03-21
D745701190PRA00050Glidewell HT™70-1190-PRA000570-1190-PRA00052024-03-21
D745701190PRA00060Glidewell HT™70-1190-PRA000670-1190-PRA00062024-03-21
D745701190PRA00070Glidewell HT™70-1190-PRA000770-1190-PRA00072024-03-21
D745701190PRA00080Glidewell HT™70-1190-PRA000870-1190-PRA00082024-03-21
D745701190PRA00090Glidewell HT™70-1190-PRA000970-1190-PRA00092024-03-21
D745701190PRA00100Glidewell HT™70-1190-PRA001070-1190-PRA00102024-03-21

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Primary DI, Brand, Company table
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