Product Name : Teeth impressions kit This product is a convenience kit including One-time Putty 3EA and 6 dental impression trays. The contents of this kit are all registered in FDA. Its…
Product Name : Teeth impressions kit This product is a convenience kit including One-time Putty 3EA and 6 dental impression trays. The contents of this kit are all registered in FDA. Its content, One-time Putty is a convenience kit that is changed only in packaging materials from Putty(MSP). These changes don’t cause any change in the original functions of Putty. Importer as Retailer is exempt from FDA’S medical device, Establishment Registration, under 21 CFR, 807.65 (e) and (i).
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.
Record
Regulatory record for Peakosil | Listed by | Neosil Co., Ltd., South Korea |
| FDA product code | ELW |
| Device type | Material, Impression |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3660 |
| 510(k) | K152180 |
| Record published | 2017-09-21 |
| Record revised | 2021-06-30 (version 8) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 4, pack of 4, carton of 25, pack of 10, box of 10 |
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.