DELTABOND 1370020
GUDID EDEL13700200
DELTABOND, Bottle 10ml
DeltaMed GmbH
Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent| Primary Device ID | EDEL13700200 |
| NIH Device Record Key | 438b9afb-0fae-455f-94e9-c9d95d1b06a5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DELTABOND |
| Version Model Number | 1370020 |
| Catalog Number | 1370020 |
| 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 | 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
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EDEL13700200 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K030832
FDA Product Code
| MQC | Mouthguard, Prescription |
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 | 2023-07-07 |
| Device Publish Date | 2023-06-29 |
Devices Manufactured by DeltaMed GmbH
| EDEL16110100 - 3Delta Etemp | 2023-09-25 3Delta Etemp A1, 1000g |
| EDEL16110200 - 3Delta Etemp | 2023-09-25 3Delta Etemp A2, 1000g |
| EDEL16110300 - 3Delta Etemp | 2023-09-25 3Delta Etemp A3, 1000g |
| EDEL3011OP0 - Renamel® Flowable Microfill | 2023-09-22 Renamel® Flowable Microfill OPAL™, Syringe 3g |
| EDEL6071OP0 - Renamel® Microfill | 2023-09-22 Renamel® Microfill OPALITE™, Syringe 4g |
| EDEL13700100 - DELTASPLINT | 2023-07-07 DELTASPLINT, 12 Rods |
| EDEL13700200 - DELTABOND | 2023-07-07DELTABOND, Bottle 10ml |
| EDEL13700200 - DELTABOND | 2023-07-07 DELTABOND, Bottle 10ml |
| EDEL13700300 - DELTAGLACE | 2023-07-07 DELTAGLACE, Bottle 10ml |
Trademark Results [DELTABOND]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DELTABOND 74633680 1948913 Live/Registered |
THERMO HYPERSIL-KEYSTONE LLC 1995-02-13 |
 DELTABOND 73669666 1480326 Dead/Cancelled |
KEYSTONE SCIENTIFIC, INC. 1987-07-01 |
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