The following data is part of a premarket notification filed by Pentron Corp. with the FDA for #24l System.
Device ID | K873878 |
510k Number | K873878 |
Device Name: | #24L SYSTEM |
Classification | Material, Tooth Shade, Resin |
Applicant | PENTRON CORP. 53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 |
Contact | Martin L Schulman |
Correspondent | Martin L Schulman PENTRON CORP. 53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-22 |
Decision Date | 1987-10-27 |