Occlude Aerosol Articulation Marking 23g – Red
Red Aerosol articulation marking spray, 23 grams
12manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (3), Anhui (3), Hebei (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| TF NEW Material SCI AND TEC Co., Ltd. | Huainan | Anhui | Manufacturer | 51 |
| Hefei Mlush Sanitary Products Co., Ltd. | Hefei | Anhui | Manufacturer | 48 |
| Henan Baistra Medical Devices Limited | Zhengzhou | Henan | Manufacturer | 34 |
| Tangshan Zhengtong Exhibition Co., Ltd. | Tangshan | Hebei | Manufacturer | 34 |
| Shanghai Smedent Medical Instrument Co., Ltd. | Shanghai | Shanghai | Repacker / relabeller | 30 |
| Anhui JM Healthcare Products Co., Ltd. | Shouxian | Anhui | Manufacturer | 25 |
| Henan Lusterdent Medical Instrument Co., Ltd. | Zhengzhou | Henan | Manufacturer | 15 |
Record
| Listed by | Pascal International, Inc., United States |
|---|---|
| FDA product code | EFH |
| Device type | Paper, Articulation |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6140 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2019-01-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature up to 122 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 05320 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AccuFilm® | Parkell, Inc. | 16 |
| Articulating paper/film | Whip-MIX Corp. | 13 |
| Bright Spot | Taub Products | 12 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 10 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 6 |
| Articulating Paper | Crosstex International | 6 |
| Ardent | Whip-MIX Corp. | 6 |
| TrollFoil | Directa AB | 6 |
| Benco | Benco Dental Supply Co. | 4 |
| Health-Tec/DHP Articulating Paper | Dental Health Products Inc | 4 |
| Advance Dental Products | THE Atlanta Dental Supply Company | 4 |
| Flex Tab | Kerr Corporation | 4 |
Showing 12 of 64. All products under Paper, Articulation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K912632 | 1992-01-17 |
| K911259 | 1991-06-06 |
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.