The following data is part of a premarket notification filed by Pentron Corp. with the FDA for Flex Span Temporary Crown & Bridge Material.
| Device ID | K021457 |
| 510k Number | K021457 |
| Device Name: | FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIAL |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | PENTRON CORP. 53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 |
| Contact | Annmarie Tenero |
| Correspondent | Annmarie Tenero PENTRON CORP. 53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-06 |
| Decision Date | 2002-08-01 |
| Summary: | summary |