Renamel® Microfill 6071OP
GUDID EDEL6071OP0
Renamel® Microfill OPALITE™, Syringe 4g
DeltaMed GmbH
Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin| Primary Device ID | EDEL6071OP0 |
| NIH Device Record Key | 770e05b2-8a7c-4ca3-92d6-9402aa0df2f5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Renamel® Microfill |
| Version Model Number | 6071OP |
| Catalog Number | 6071OP |
| 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 *protect from direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *protect from direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *protect from direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *protect from direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *protect from direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *protect from direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *protect from direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *protect from direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *protect from direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *protect from direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *protect from direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *protect from direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *protect from direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *protect from direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *protect from direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *protect from direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *protect from direct sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EDEL6071OP0 [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 | 2023-09-22 |
| Device Publish Date | 2023-09-14 |
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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