Renamel® Microfill 615SB1
GUDID EDEL615SB10
Renamel® Microfill SuperBrite 1, Syringe 2g
DeltaMed GmbH
Dental composite resin| Primary Device ID | EDEL615SB10 |
| NIH Device Record Key | ab467d36-4d27-4642-abee-ace796417e2d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Renamel® Microfill |
| Version Model Number | 615SB1 |
| Catalog Number | 615SB1 |
| 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 |
| 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 | D779615SB10 [Previous] |
| HIBCC | EDEL615SB10 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K172707
FDA Product Code
| EBF | Material, Tooth Shade, 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 | 2023-06-08 |
| Device Publish Date | 2023-05-31 |
On-Brand Devices [Renamel® Microfill]
| EDEL615SB30 | Renamel® Microfill SuperBrite 3, Syringe 2g |
| EDEL615SB20 | Renamel® Microfill SuperBrite 2, Syringe 2g |
| EDEL615SB10 | Renamel® Microfill SuperBrite 1, Syringe 2g |
| EDEL615A350 | Renamel® Microfill Enamel Body A3.5, Syringe 2g |
| EDEL615A250 | Renamel® Microfill Enamel Body A2.5, Syringe 2g |
| EDEL6151MI0 | Renamel® Microfill Enamel Medium Incisal, Syringe 2g |
| EDEL6151LI0 | Renamel® Microfill Enamel Light Incisal, Syringe 2g |
| EDEL6151D30 | Renamel® Microfill Enamel Body D3, Syringe 2g |
| EDEL6151D20 | Renamel® Microfill Enamel Body D2, Syringe 2g |
| EDEL6151C40 | Renamel® Microfill Enamel Body C4, Syringe 2g |
| EDEL6151C30 | Renamel® Microfill Enamel Body C3, Syringe 2g |
| EDEL6151C20 | Renamel® Microfill Enamel Body C2, Syringe 2g |
| EDEL6151C10 | Renamel® Microfill Enamel Body C1, Syringe 2g |
| EDEL6151B30 | Renamel® Microfill Enamel Body B3, Syringe 2g |
| EDEL6151B20 | Renamel® Microfill Enamel Body B2, Syringe 2g |
| EDEL6151B10 | Renamel® Microfill Enamel Body B1, Syringe 2g |
| EDEL6151A40 | Renamel® Microfill Enamel Body A4, Syringe 2g |
| EDEL6151A30 | Renamel® Microfill Enamel Body A3, Syringe 2g |
| EDEL6151A20 | Renamel® Microfill Enamel Body A2, Syringe 2g |
| EDEL6151A10 | Renamel® Microfill Enamel Body A1, Syringe 2g |
| EDEL607A350 | Renamel® Microfill Enamel Body A3.5, Syringe 4g |
| EDEL607A250 | Renamel® Microfill Enamel Body A2.5, Syringe 4g |
| EDEL607A150 | Renamel® Microfill Enamel Body A1.5, Syringe 4g |
| EDEL6073S30 | Renamel® Microfill SuperBrite 3, 20 Compules |
| EDEL6073S20 | Renamel® Microfill SuperBrite 2, 20 Compules |
| EDEL6073S10 | Renamel® Microfill SuperBrite 1, 20 Compules |
| EDEL6073MI0 | Renamel® Microfill Enamel Medium Incisal, 20 Compules |
| EDEL6073LO0 | Renamel® Microfill Enamel Light Opaque, 20 Compules |
| EDEL6073LI0 | Renamel® Microfill Enamel Light Incisal, 20 Compules |
| EDEL6073DI0 | Renamel® Microfill Enamel Dark Incisal, 20 Compules |
| EDEL6073D40 | Renamel® Microfill Enamel Body D4, 20 Compules |
| EDEL6073D30 | Renamel® Microfill Enamel Body D3, 20 Compules |
| EDEL6073D20 | Renamel® Microfill Enamel Body D2, 20 Compules |
| EDEL6073C50 | Renamel® Microfill Enamel Body C5, 20 Compules |
| EDEL6073C40 | Renamel® Microfill Enamel Body C4, 20 Compules |
| EDEL6073C30 | Renamel® Microfill Enamel Body C3, 20 Compules |
| EDEL6073C20 | Renamel® Microfill Enamel Body C2, 20 Compules |
| EDEL6073C10 | Renamel® Microfill Enamel Body C1, 20 Compules |
| EDEL6073B40 | Renamel® Microfill Enamel Body B4, 20 Compules |
| EDEL6073B30 | Renamel® Microfill Enamel Body B3, 20 Compules |
| EDEL6073B20 | Renamel® Microfill Enamel Body B2, 20 Compules |
| EDEL6073B10 | Renamel® Microfill Enamel Body B1, 20 Compules |
| EDEL6073B00 | Renamel® Microfill Enamel Body B-Zero, 20 Compules |
| EDEL6073A60 | Renamel® Microfill Enamel Body A6, 20 Compules |
| EDEL6073A50 | Renamel® Microfill Enamel Body A5, 20 Compules |
| EDEL6073A40 | Renamel® Microfill Enamel Body A4, 20 Compules |
| EDEL6073A30 | Renamel® Microfill Enamel Body A3, 20 Compules |
| EDEL6073A20 | Renamel® Microfill Enamel Body A2, 20 Compules |
| EDEL6073A10 | Renamel® Microfill Enamel Body A1, 20 Compules |
| EDEL6073350 | Renamel® Microfill Enamel Body A3.5, 20 Compules |
Trademark Results [Renamel]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RENAMEL 79088119 not registered Dead/Abandoned |
Sangi Co., Ltd. 2010-08-25 |
 RENAMEL 76580246 not registered Dead/Abandoned |
Sangi Co., Ltd. 2004-03-10 |
 RENAMEL 74364089 not registered Dead/Abandoned |
KABUSHIKI KAISHA SANGI 1993-03-01 |
 RENAMEL 73354552 1280429 Live/Registered |
Cosmedent, Inc. 1982-03-15 |
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