Sample Embrace PIT & Fissure Sealant
0.6 mL syringe + mixing tips (off-white shade)
1manufacturer
2catalogue numbers in this listing
10510(k) clearances naming this product code
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 | Pulpdent Corporation, United States |
|---|---|
| FDA product code | EBC |
| Device type | Sealant, Pit And Fissure, And Conditioner |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3765 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K020287 |
| Record published | 2018-08-10 |
| Record revised | 2018-12-05 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Sizes | Total volume 0.6 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SEMSW | Total Volume 0.6 ml | In distribution |
| SEMS | Total Volume 0.6 ml | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K172169 | 2018-01-05 |
| K113818 | 2012-03-21 |
| K052281 | 2006-02-08 |
| K020287 | 2002-04-12 |
| K963921 | 1996-11-12 |
| K945378 | 1995-01-17 |
| K932794 | 1993-09-20 |
| K911287 | 1991-06-10 |
| K902022 | 1990-07-20 |
| K902023 | 1990-07-13 |
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.