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Infiltration Concept. Resin Infiltration - Smooth Surface. The effective approach to treating withe spots. Content: 2 treatments units (each contains 1 syringe Icon-Etch @ 0.45 ml, 1…
Infiltration Concept. Resin Infiltration – Smooth Surface. The effective approach to treating withe spots. Content: 2 treatments units (each contains 1 syringe Icon-Etch @ 0.45 ml, 1 syringe Icon-Dry @0.45 ml, 1 syringe Icon-Infiltrant @ 0.45 ml), accessories.
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Rizhao Huge Biomaterials Company, Ltd. | Rizhao | Shandong | Manufacturer | 7 |
Record
| Listed by | DMG Chemisch Pharmazeutische Fabrik Gmbh, Germany |
|---|---|
| FDA product code | EBC |
| Device type | Sealant, Pit And Fissure, And Conditioner |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3765 |
| Establishment | Manufacturer |
| 510(k) | K100062 |
| Record published | 2016-09-22 |
| Record revised | 2019-05-14 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Special storage condition: After use, dispose of the product in household waste.; Storage environment temperature 2 to 25 °C; Storage environment temperature 36 to 77 °F |
| Packaging | Pack of 2, pack of 7 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 220402 | In distribution | |
| 220403 | In distribution | |
| 220401 | In distribution | |
| 220400 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| UltraSeal XT | Ultradent Products Inc. | 22 |
| SciPharm Pit & Fissure Sealer Bonding Agent | Scientific Pharmaceuticals, Inc. | 20 |
| Orthosource | Orthosource, Inc. | 20 |
| Visalys Fill | Kettenbach Gmbh & Co KG | 14 |
| Riva Protect | SDI Ltd. | 14 |
| Venus Diamond Flow | Kulzer SRL | 9 |
| Conseal | SDI Ltd. | 9 |
| Delton® | Dentsply Professional | 9 |
| Helioseal Clear F F Plus | Ivoclar Vivadent Aktiengesellschaft | 8 |
| Patterson® | Patterson Dental Supply, Inc. | 8 |
| Clinpro™ | 3M Company | 7 |
| Visalys Flow | Kettenbach Gmbh & Co KG | 7 |
Showing 12 of 133. All products under Sealant, Pit And Fissure, And Conditioner
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.