Camouflage 70-1151-CMU0032
GUDID D745701151CMU00321
Camouflage Universal Enamel, Shade B2, 20 0.2g Capsules
Prismatik Dentalcraft, Inc
Dental composite resin| Primary Device ID | D745701151CMU00321 |
| NIH Device Record Key | 37728b09-a796-4615-bf00-45c948f3b622 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Camouflage |
| Version Model Number | 70-1151-CMU0032 |
| Catalog Number | 70-1151-CMU0032 |
| Company DUNS | 022761689 |
| Company Name | Prismatik Dentalcraft, Inc |
| Device Count | 20 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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(949)440-2629 |
| Shelly.Harris@glidewelldental.com | |
| Phone | +1(949)440-2629 |
| Shelly.Harris@glidewelldental.com | |
| Phone | +1(949)440-2629 |
| Shelly.Harris@glidewelldental.com | |
| Phone | +1(949)440-2629 |
| Shelly.Harris@glidewelldental.com | |
| Phone | +1(949)440-2629 |
| Shelly.Harris@glidewelldental.com | |
| Phone | +1(949)440-2629 |
| Shelly.Harris@glidewelldental.com | |
| Phone | +1(949)440-2629 |
| Shelly.Harris@glidewelldental.com | |
| Phone | +1(949)440-2629 |
| Shelly.Harris@glidewelldental.com | |
| Phone | +1(949)440-2629 |
| Shelly.Harris@glidewelldental.com | |
| Phone | +1(949)440-2629 |
| Shelly.Harris@glidewelldental.com | |
| Phone | +1(949)440-2629 |
| Shelly.Harris@glidewelldental.com | |
| Phone | +1(949)440-2629 |
| Shelly.Harris@glidewelldental.com | |
| Phone | +1(949)440-2629 |
| Shelly.Harris@glidewelldental.com | |
| Phone | +1(949)440-2629 |
| Shelly.Harris@glidewelldental.com | |
| Phone | +1(949)440-2629 |
| Shelly.Harris@glidewelldental.com | |
| Phone | +1(949)440-2629 |
| Shelly.Harris@glidewelldental.com | |
| Phone | +1(949)440-2629 |
| Shelly.Harris@glidewelldental.com |
Device Dimensions
| Weight | 0.2 Gram |
| Weight | 0.2 Gram |
| Weight | 0.2 Gram |
| Weight | 0.2 Gram |
| Weight | 0.2 Gram |
| Weight | 0.2 Gram |
| Weight | 0.2 Gram |
| Weight | 0.2 Gram |
| Weight | 0.2 Gram |
| Weight | 0.2 Gram |
| Weight | 0.2 Gram |
| Weight | 0.2 Gram |
| Weight | 0.2 Gram |
| Weight | 0.2 Gram |
| Weight | 0.2 Gram |
| Weight | 0.2 Gram |
| Weight | 0.2 Gram |
Operating and Storage Conditions
| Handling Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Away From Sun |
| Storage Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Away From Sun |
| Storage Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Away From Sun |
| Storage Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Away From Sun |
| Storage Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Away From Sun |
| Storage Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Away From Sun |
| Storage Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Away From Sun |
| Storage Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Away From Sun |
| Storage Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Away From Sun |
| Storage Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Away From Sun |
| Storage Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Away From Sun |
| Storage Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Away From Sun |
| Storage Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Away From Sun |
| Storage Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Away From Sun |
| Storage Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Away From Sun |
| Storage Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Away From Sun |
| Storage Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Away From Sun |
| Storage Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D745701151CMU00320 [Unit of Use] |
| HIBCC | D745701151CMU00321 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K133850
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 | 2016-09-23 |
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 |
Trademark Results [Camouflage]
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