DiaPlus A2001-2101
GUDID 08806383565141
DiaPlus is a photopolymerization type dentine and enamel adhesive as a 5th generation dentine adhesion system that can be applied to all types of composite resin restorations.
DiaDent Group International
Dentine bonding agent/set| Primary Device ID | 08806383565141 |
| NIH Device Record Key | cf8560f9-6442-4f85-9892-37541a866f71 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DiaPlus |
| Version Model Number | DiaPlus 5ml |
| Catalog Number | A2001-2101 |
| Company DUNS | 687789453 |
| Company Name | DiaDent Group International |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from Sunlight. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08806383565141 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K192392
FDA Product Code
| KLE | Agent, Tooth Bonding, Resin |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-21 |
| Device Publish Date | 2020-08-13 |
Devices Manufactured by DiaDent Group International
| 08806383534758 - GUTTA PERCHA OBTURATOR | 2023-07-05 GUTTA PERCHA OBTURATOR is used to root canal filing material. |
| 08806383551014 - Endo Shaping Blocks | 2023-07-05 Clear acrylic blocks with high transparency for new technique training. |
| 08806383565608 - DISPOSABLE TIPS | 2023-07-05 Disposable Tip for DiaFil Flow |
| 08806383565615 - DISPOSABLE TIPS | 2023-07-05 Disposable Tips for DiaEtch |
| 08806383565660 - DISPOSABLE TIPS | 2023-07-05 Disposable Tips for DiaFil Flow |
| 08806383565677 - DISPOSABLE TIPS | 2023-07-05 Disposable Tips for DiaEtch |
| 08806383576475 - GUTTA PERCHA POINTS | 2023-07-05 Gutta Percha Points is used to root canal filing material. |
| 08806383576482 - GUTTA PERCHA POINTS | 2023-07-05 Gutta Percha Points is used to root canal filing material. |
Trademark Results [DiaPlus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DIAPLUS 88698131 not registered Live/Pending |
Choe, Scott Yong-Ik 2019-11-19 |
 DIAPLUS 75802543 2372903 Dead/Cancelled |
Struers A/S, Denmark 1999-09-20 |
 DIAPLUS 74192697 not registered Dead/Abandoned |
Idemitsu Petrochemical Co., Ltd. 1991-08-08 |
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