B4® Pre-Impression Surface Optimizer
B4® Pre-Impression Surface Optimizer Bottle Sample
6manufacturers in China registered for this device type
2catalogue numbers in this listing
19510(k) clearances naming this product code
Who Else Makes It
Concentrated in Henan (1), Shandong (1), Jiangxi (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hygedent Inc. | Beijing | Beijing | Contract manufacturer | 1 |
| Zhengzhou Huaer Electro-Optics Technology Co., Ltd. | Zhengzhou | Henan | Contract manufacturer | 21 |
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Jiangxi Dentalbright Technology Co., Ltd. | Jiujiang | Jiangxi | Contract manufacturer | 12 |
| Sunrise Dental Laboratory, Ltd. | Kowloon | Hong Kong | Manufacturer | 5 |
| Chemoment Materials Co., Ltd. | Hefei | Anhui | Manufacturer | 3 |
Record
| Listed by | Dentsply LLC, United States |
|---|---|
| FDA product code | ELW |
| Device type | Material, Impression |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3660 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2022-05-12 |
| Record revised | 2022-10-03 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 10 to 24 °C; Special storage condition: Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.; Special storage condition: Keep out of direct sunlight and store in a well-ventilated place.; Special storage condition: Do not use after expiration date.; Special storage condition: Protect from moisture.; Special storage condition: Do not freeze. |
| Sizes | Total volume 6 ml |
| Distribution end date | 2022-04-21 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 678132 | 1 Bottle B4® (6mL), 1 Dispensing Well, 50 Flocked Applicator Tips | In distribution |
| 678131 | Total Volume 6 ml | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Henry Schein | Henry Schein, Inc. | 164 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 124 |
| EXAlence™ | GC America Inc. | 96 |
| MARK3 | Cargus International, Inc | 75 |
| Panasil | Kettenbach Gmbh & Co KG | 73 |
| Aquasil Ultra Smart Wetting® Impression Material Cartridge System | Dentsply LLC | 72 |
| DentMix | IPB Inc | 70 |
| Affinis | Coltène/Whaledent AG | 67 |
| Take 1 Advanced | Kerr Corporation | 54 |
| MDC Dental | MDC Dental | 49 |
| Elastomeric Impression Material | Shandong Huge Dental Material Corporation | 46 |
| Splash® | DEN-MAT Holdings, LLC | 44 |
Showing 12 of 1,245. All products under Material, Impression
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K113406 | 2012-02-13 |
| K061427 | 2006-06-26 |
| K021416 | 2002-05-13 |
| K021413 | 2002-05-10 |
| K021410 | 2002-05-08 |
| K973781 | 1997-12-11 |
| K973782 | 1997-12-04 |
| K970433 | 1997-03-27 |
| K952614 | 1996-08-13 |
| K943574 | 1994-08-23 |
| K940685 | 1994-04-28 |
| K884166 | 1989-04-17 |
| K883842 | 1989-03-17 |
| K863288 | 1986-12-01 |
| K862879 | 1986-09-25 |
| K860146 | 1986-03-17 |
| K802362 | 1980-10-10 |
| K801587 | 1980-07-21 |
| K781151 | 1978-08-31 |
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.