Camouflage
- Primary DI
- D745701151CMU00040
- Brand
- Camouflage
- Company
- Prismatik Dentalcraft, Inc
- Model
- 70-1151-CMU0004
- Catalog number
- 70-1151-CMU0004
- Device description
- Camouflage Universal Enamel, Bleach, 4g Syringe
- Published
- 2016-09-23
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
Contact Domains#
glidewelldental.comProduct Codes#
| Code | Name |
|---|---|
| EBF | MATERIAL, TOOTH SHADE, RESIN |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | Dental | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K133850 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| D745701151CMU00040 | Primary | HIBCC | 0 |
GMDN Terms#
| Term | Definition |
|---|---|
| Dental composite resin | A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Weight | 4 | Gram |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Handling Environment Temperature | 2 Degrees Celsius | 24 Degrees Celsius | |
| Special Storage Condition, Specify | 0 | 0 | Away From Sun |
| Storage Environment Temperature | 2 Degrees Celsius | 24 Degrees Celsius |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +1(949)440-2629 | Shelly.Harris@glidewelldental.com |
Regulatory Flags#
- DUNS number
- 022761689
- Device count
- 1
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| D745701122OMB01611 | Obsidian | 70-1122-OMB0161 | 70-1122-OMB0161 | 2016-09-23 |
| D74570BIOBGP050 | Newport Biologics Bone Graft Putty Mineral Collagen Composite | 70-BIO-BGP05 | 70-BIO-BGP05 | 2016-09-24 |
| D74570BIOBGP100 | Newport Biologics Bone Graft Putty Mineral Collagen Composite | 70-BIO-BGP10 | 70-BIO-BGP10 | 2016-10-07 |
| D74570BIOBGP200 | Newport Biologics Bone Graft Putty Mineral Collagen Composite | 70-BIO-BGP20 | 70-BIO-BGP20 | 2016-09-24 |
| D745SN3D0 | Silent Nite 3D Sleep Appliance | SN3D | SN3D | 2026-10-07 |
| D745MAPCSDLA0 | Silent Nite 3D Sleep Appliance | MA-PC-SD-LA | MA-PC-SD-LA | 2024-04-15 |
| D745MAPCSDOP0 | Silent Nite 3D Sleep Appliance | MA-PC-SD-OP | MA-PC-SD-OP | 2024-04-15 |
| D745MAPCSDUA0 | Silent Nite 3D Sleep Appliance | MA-PC-SD-UA | MA-PC-SD-UA | 2024-04-15 |
| D745701181MIL001610150 | fastdesign.io | 70-1181-MIL0016 | 70-1181-MIL0016 | 2026-03-16 |
| D745701181MIL046710150 | fastdesign.io | 70-1181-MIL0467 | 70-1181-MIL0467 | 2026-03-16 |
| D745701072PRC00010 | Inclusive | 70-1072-PRC0001 | 70-1072-PRC0001 | 2015-10-24 |
| D745701072PRC00580 | Inclusive | 70-1072-PRC0058 | 70-1072-PRC0058 | 2015-10-24 |
| D745701173COM00040 | Inclusive | 70-1173-COM0004 | 70-1173-COM0004 | 2016-10-07 |
| D745701122SHS01451 | Obsidian | 70-1122-SHS0145 | 70-1122-SHS0145 | 2016-09-23 |
| D745701182BZE05590 | BruxZir® | 70-1182-BZE0559 | 70-1182-BZE0559 | 2026-07-07 |
| D745701182BZE05600 | BruxZir® | 70-1182-BZE0560 | 70-1182-BZE0560 | 2026-07-07 |
| D745701182BZE05610 | BruxZir® | 70-1182-BZE0561 | 70-1182-BZE0561 | 2026-07-07 |
| D745701182BZE05640 | BruxZir® | 70-1182-BZE0564 | 70-1182-BZE0564 | 2026-07-07 |
| D745701182BZE05760 | BruxZir® | 70-1182-BZE0576 | 70-1182-BZE0576 | 2026-07-07 |
| D745701182BZE05770 | BruxZir® | 70-1182-BZE0577 | 70-1182-BZE0577 | 2026-07-07 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 06970006745677 | Universal Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746575 | TrusFIL-Flow Flowable Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746582 | TrusFIL-Flow Flowable Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746599 | TrusFIL-Flow Flowable Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746605 | TrusFIL-Flow Flowable Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746612 | TrusFIL-Flow Flowable Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746629 | TrusFIL-Flow Flowable Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746636 | TrusFIL-Flow Flowable Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746643 | TrusFIL-Flow Flowable Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746650 | TrusFIL-Flow Flowable Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746667 | TrusFIL-Flow Flowable Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746674 | TrusFIL-Flow Flowable Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746681 | TrusFIL-Flow Flowable Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746698 | TrusFIL-Flow Flowable Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746704 | Universal Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746711 | Universal Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746728 | Universal Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746735 | Universal Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746742 | Universal Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746759 | Universal Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746766 | Universal Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746773 | Universal Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746780 | Universal Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746797 | Universal Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746803 | Universal Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746810 | Universal Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746827 | Universal Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06972220489016 | TrusFIL-Flow Flowable Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06972220489023 | TrusFIL-Flow Flowable Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06972220489047 | TrusFIL-Flow Flowable Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |