OptiGuard
- Primary DI
- 00841396106972
- Brand
- OptiGuard
- Company
- Kerr Corporation
- Model
- 25880
- Catalog number
- 25880
- Device description
- Light Cure Sealant; Refill
- Published
- 2016-08-01
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| EBF | MATERIAL, TOOTH SHADE, RESIN |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| EBF | Material, Tooth Shade, Resin | Dental | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00841396106972 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00841396106972 | 00841396106972 | 841396106972 | 0841396106972 |
GMDN Terms
| Term | Definition |
|---|
| Dental unfilled resin sealant/coating | A non-sterile, resin-based dental material intended for professional use as a sealant, coating, and/or glazing material during dental restoration (e.g., pit/fissure sealing and/or restorative composite resin sealing/coating), whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of an unfilled resin; it does not include any significant inorganic filler materials and is therefore not classed as a composite resin. It may be preloaded into an applicator. After application, this device cannot be reused. |
Device Sizes
| Type | Value | Unit |
|---|
| Total Volume | 5 | Milliliter |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | Store at ambient temperature |
Regulatory Flags
- DUNS number
- 199354556
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00815967025856 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-24 |
| 00815967025863 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-24 |
| 00815967025870 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-24 |
| 00815967021438 | OptiComp | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967021797 | OptiComp | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967027447 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028161 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028178 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028185 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028192 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028208 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028215 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028222 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028239 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028246 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028253 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028260 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028277 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028284 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028291 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028307 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028314 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028321 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028338 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028345 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028352 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028369 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028376 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028383 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028390 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
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