COSMESEAL™ Filled 61710W
GUDID EDEL61710W0
COSMESEAL® Filled, Syringe 1g
DeltaMed GmbH
Dental composite resin| Primary Device ID | EDEL61710W0 |
| NIH Device Record Key | c790bf70-b749-41dd-87c6-812c008db3ec |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | COSMESEAL™ Filled |
| Version Model Number | 61710W |
| Catalog Number | 61710W |
| Company DUNS | 344805101 |
| Company Name | DeltaMed GmbH |
| 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 | 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 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D77961710W0 [Previous] |
| HIBCC | EDEL61710W0 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K042823
FDA Product Code
| EBC | Sealant, Pit And Fissure, And Conditioner |
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 | 2023-06-13 |
| Device Publish Date | 2023-06-05 |
Devices Manufactured by DeltaMed GmbH
| EDEL6251010 - Insure® UNIVERSAL | 2024-09-02 Insure® UNIVERSAL Clear, Syringe 3g |
| EDEL6251020 - Insure® UNIVERSAL | 2024-09-02 Insure® UNIVERSAL Yellow Red Light, Syringe 3g |
| EDEL6251030 - Insure® UNIVERSAL | 2024-09-02 Insure® UNIVERSAL Yellow Red Universal, Syringe 3g |
| EDEL6251040 - Insure® UNIVERSAL | 2024-09-02 Insure® UNIVERSAL Grey Light, Syringe 3g |
| EDEL6251050 - Insure® UNIVERSAL | 2024-09-02 Insure® UNIVERSAL White Opaque, Syringe 3g |
| EDEL6251060 - Insure® UNIVERSAL | 2024-09-02 Insure® UNIVERSAL Yellow Opaque, Syringe 3g |
| EDEL6251070 - Insure® UNIVERSAL | 2024-09-02 Insure® UNIVERSAL Pink Opaque, Syringe 3g |
| EDEL625AMC0 - Insure® UNIVERSAL AutoMix | 2024-09-02 Insure® UNIVERSAL AutoMix Clear, Syringe 8g |
Trademark Results [COSMESEAL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COSMESEAL 78462776 3099189 Live/Registered |
Cosmedent, Inc. 2004-08-05 |
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