CAMouflage 70-1000-CMN0004

GUDID D745701000CMN00040

CAMouflage NOW Milling Blocks & Bonding Kit GD-Mandrel A2 HT

Prismatik Dentalcraft, Inc

Custom-made dental composite resin kit Custom-made dental composite resin kit Custom-made dental composite resin kit Custom-made dental composite resin kit Custom-made dental composite resin kit Custom-made dental composite resin kit Custom-made dental composite resin kit Custom-made dental composite resin kit Custom-made dental composite resin kit Custom-made dental composite resin kit Custom-made dental composite resin kit Custom-made dental composite resin kit Custom-made dental composite resin kit Custom-made dental composite resin kit Custom-made dental composite resin kit Custom-made dental composite resin kit Custom-made dental composite resin kit

• Primary Device ID: D745701000CMN00040
• NIH Device Record Key: d967ca51-fd33-4334-8e16-889575f199ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAMouflage
• Version Model Number: 70-1000-CMN0004
• Catalog Number: 70-1000-CMN0004
• Company DUNS: 022761689
• Company Name: Prismatik Dentalcraft, Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Upon Receipt
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Upon Receipt
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Upon Receipt
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Upon Receipt
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Upon Receipt
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Upon Receipt
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Upon Receipt
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Upon Receipt
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Upon Receipt
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Upon Receipt
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Upon Receipt
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Upon Receipt
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Upon Receipt
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Upon Receipt
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Upon Receipt
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Upon Receipt
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate Upon Receipt

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D745701000CMN00040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160425

FDA Product Code

• EBF: MATERIAL, TOOTH SHADE, RESIN

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-08-22
• Device Publish Date: 2018-02-19

On-Brand Devices [CAMouflage]

• D745701152CMF00181: Camouflage Flowable Enamel, Shade C4, 20 0.2g Capsules
• D745701152CMF00171: Camouflage Flowable Enamel, Shade B1, 20 0.2g Capsules
• D745701152CMF00161: Camouflage Flowable Enamel, Shade A4, 20 0.2g Capsules
• D745701152CMF00151: Camouflage Flowable Enamel, Shade A3.5, 20 0.2g Capsules
• D745701152CMF00141: Camouflage Flowable Enamel, Shade A3, 20 0.2g Capsules
• D745701152CMF00131: Camouflage Flowable Enamel, Shade A2, 20 0.2g Capsules
• D745701152CMF00121: Camouflage Flowable Enamel, Shade A1, 20 0.2g Capsules
• D745701152CMF00111: Camouflage Flowable Enamel, Bleach, 20 0.2g Capsules
• D745701152CMF00101: Camouflage Flowable Dentin, Shade A2, 20 0.2g Capsules
• D745701152CMF00090: Camouflage Flowable Enamel, Shade C4, 4g Syringe
• D745701152CMF00080: Camouflage Flowable Enamel, Shade B1, 4g Syringe
• D745701152CMF00070: Camouflage Flowable Enamel, Shade A4, 4g Syringe
• D745701152CMF00060: Camouflage Flowable Enamel, Shade A3.5, 4g Syringe
• D745701152CMF00050: Camouflage Flowable Enamel, Shade A3, 4g Syringe
• D745701152CMF00040: Camouflage Flowable Enamel, Shade A2, 4g Syringe
• D745701152CMF00030: Camouflage Flowable Enamel, Shade A1, 4g Syringe
• D745701152CMF00020: Camouflage Flowable Enamel, Bleach , 4g Syringe
• D745701152CMF00010: Camouflage Flowable Dentin, Shade A2, 4g Syringe
• D745701151CMU00451: Camouflage Universal Enamel Sample, Shade A2, 3 0.2g Capsules
• D745701151CMU00421: Camouflage Universal Incisal, 20 0.2g Capsules
• D745701151CMU00411: Camouflage Universal Enamel, Shade D4, 20 0.2g Capsules
• D745701151CMU00401: Camouflage Universal Enamel, Shade D3, 20 0.2g Capsules
• D745701151CMU00391: Camouflage Universal Enamel, Shade D2, 20 0.2g Capsules
• D745701151CMU00381: Camouflage Universal Enamel, Shade C4, 20 0.2g Capsules
• D745701151CMU00371: Camouflage Universal Enamel, Shade C3, 20 0.2g Capsules
• D745701151CMU00361: Camouflage Universal Enamel, Shade C2, 20 0.2g Capsules
• D745701151CMU00351: Camouflage Universal Enamel, Shade C1, 20 0.2g Capsules
• D745701151CMU00341: Camouflage Universal Enamel, Shade B4, 20 0.2g Capsules
• D745701151CMU00331: Camouflage Universal Enamel, Shade B3, 20 0.2g Capsules
• D745701151CMU00321: Camouflage Universal Enamel, Shade B2, 20 0.2g Capsules
• D745701151CMU00311: Camouflage Universal Enamel, Shade B1, 20 0.2g Capsules
• D745701151CMU00301: Camouflage Universal Enamel, Shade A4, 20 0.2g Capsules
• D745701151CMU00291: Camouflage Universal Enamel, Shade A3.5, 20 0.2g Capsules
• D745701151CMU00281: Camouflage Universal Enamel, Shade A3, 20 0.2g Capsules
• D745701151CMU00271: Camouflage Universal Enamel, Shade A2, 20 0.2g Capsules
• D745701151CMU00261: Camouflage Universal Enamel, Shade A1, 20 0.2g Capsules
• D745701151CMU00251: Camouflage Universal Enamel, Bleach, 20 0.2g Capsules
• D745701151CMU00241: Camouflage Universal Dentin, Shade B1, 20 0.2g Capsules
• D745701151CMU00231: Camouflage Universal Dentin, Shade A3, 20 0.2g Capsules
• D745701151CMU00221: Camouflage Universal Dentin, Shade A2, 20 0.2g Capsules
• D745701151CMU00210: Camouflage Universal Incisal, 4g Syringe
• D745701151CMU00200: Camouflage Universal Enamel, Shade D4, 4g Syringe
• D745701151CMU00190: Camouflage Universal Enamel, Shade D3, 4g Syringe
• D745701151CMU00180: Camouflage Universal Enamel, Shade D2, 4g Syringe
• D745701151CMU00170: Camouflage Universal Enamel, Shade C4, 4g Syringe
• D745701151CMU00160: Camouflage Universal Enamel, Shade C3, 4g Syringe
• D745701151CMU00150: Camouflage Universal Enamel, Shade C2, 4g Syringe
• D745701151CMU00140: Camouflage Universal Enamel, Shade C1, 4g Syringe
• D745701151CMU00130: Camouflage Universal Enamel, Shade B4, 4g Syringe
• D745701151CMU00120: Camouflage Universal Enamel, Shade B3, 4g Syringe