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
| 04260635981587 - RS VIVO Tray | 2025-08-06 RS VIVO Tray 1000g |
| 04260635981594 - RS VIVO Try-In | 2025-08-06 RS VIVO Try-In 1000g |
| EDEL16211210 - 3Delta Try-In XT | 2025-08-06 3Delta Try-In XT 1000g |
| EDEL16216200 - 3Delta Tray Rose | 2025-08-06 3Delta Tray Rose 1000g |
| 04260635981600 - RS VIVO C&B Ultimate | 2025-07-03 RS VIVO C&B Ultimate A1 500g |
| 04260635981617 - RS VIVO C&B Ultimate | 2025-07-03 RS VIVO C&B Ultimate A2 500g |
| 04260635981624 - RS VIVO C&B Ultimate | 2025-07-03 RS VIVO C&B Ultimate A3 500g |
| 04260635981631 - RS VIVO C&B Ultimate | 2025-07-03 RS VIVO C&B Ultimate B1 500g |
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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