DELTABOND 1370020
GUDID EDEL13700200
DELTABOND, Bottle 10ml
DeltaMed GmbH
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
| 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 [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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