The following data is part of a premarket notification filed by Global Top, Inc. with the FDA for Dental Porcelain (glass Powder), Top-ceram T-1, T1, T2, T3, T4.
| Device ID | K081200 |
| 510k Number | K081200 |
| Device Name: | DENTAL PORCELAIN (GLASS POWDER), TOP-CERAM T-1, T1, T2, T3, T4 |
| Classification | Powder, Porcelain |
| Applicant | GLOBAL TOP, INC. #708 LE-MEILLEUR TOWN, 837-19 GANGNAM-GU Seoul, KR 135-937 |
| Contact | Claude Yang |
| Correspondent | Claude Yang GLOBAL TOP, INC. #708 LE-MEILLEUR TOWN, 837-19 GANGNAM-GU Seoul, KR 135-937 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-28 |
| Decision Date | 2008-08-08 |
| Summary: | summary |