FDA.reportPublic FDA data

CAMouflage

Primary DI
D745701000CMN00010
Brand
CAMouflage
Company
Prismatik Dentalcraft, Inc
Model
70-1000-CMN0001
Catalog number
70-1000-CMN0001
Device description
CAMouflage NOW Milling Blocks & Bonding Kit GD-Mandrel Variety Pack
Published
2018-02-19
Public version status
Update
Distribution status
Not 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
D745701000CMN00010PrimaryHIBCC0

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Refrigerate Upon Receipt
Storage Environment Temperature4 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
022761689
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D745701122OMB01611Obsidian70-1122-OMB016170-1122-OMB01612016-09-23
D74570BIOBGP050Newport Biologics Bone Graft Putty Mineral Collagen Composite70-BIO-BGP0570-BIO-BGP052016-09-24
D74570BIOBGP100Newport Biologics Bone Graft Putty Mineral Collagen Composite70-BIO-BGP1070-BIO-BGP102016-10-07
D74570BIOBGP200Newport Biologics Bone Graft Putty Mineral Collagen Composite70-BIO-BGP2070-BIO-BGP202016-09-24
D745SN3D0Silent Nite 3D Sleep ApplianceSN3DSN3D2026-10-07
D745MAPCSDLA0Silent Nite 3D Sleep ApplianceMA-PC-SD-LAMA-PC-SD-LA2024-04-15
D745MAPCSDOP0Silent Nite 3D Sleep ApplianceMA-PC-SD-OPMA-PC-SD-OP2024-04-15
D745MAPCSDUA0Silent Nite 3D Sleep ApplianceMA-PC-SD-UAMA-PC-SD-UA2024-04-15
D745701181MIL001610150fastdesign.io70-1181-MIL001670-1181-MIL00162026-03-16
D745701181MIL046710150fastdesign.io70-1181-MIL046770-1181-MIL04672026-03-16
D745701072PRC00010Inclusive70-1072-PRC000170-1072-PRC00012015-10-24
D745701072PRC00580Inclusive70-1072-PRC005870-1072-PRC00582015-10-24
D745701173COM00040Inclusive70-1173-COM000470-1173-COM00042016-10-07
D745701122SHS01451Obsidian70-1122-SHS014570-1122-SHS01452016-09-23
D745701182BZE05590BruxZir®70-1182-BZE055970-1182-BZE05592026-07-07
D745701182BZE05600BruxZir®70-1182-BZE056070-1182-BZE05602026-07-07
D745701182BZE05610BruxZir®70-1182-BZE056170-1182-BZE05612026-07-07
D745701182BZE05640BruxZir®70-1182-BZE056470-1182-BZE05642026-07-07
D745701182BZE05760BruxZir®70-1182-BZE057670-1182-BZE05762026-07-07
D745701182BZE05770BruxZir®70-1182-BZE057770-1182-BZE05772026-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970006745677Universal Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746575TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746582TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746599TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746605TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746612TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746629TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746636TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746643TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746650TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746667TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746674TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746681TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746698TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746704Universal Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746711Universal Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746728Universal Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746735Universal Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746742Universal Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746759Universal Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746766Universal Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746773Universal Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
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06970006746797Universal Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746803Universal Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746810Universal Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746827Universal Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06972220489016TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06972220489023TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06972220489047TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25