The following data is part of a premarket notification filed by Dent-x Co. with the FDA for Model 410 Dental X-ray Film Processors.
Device ID | K874118 |
510k Number | K874118 |
Device Name: | MODEL 410 DENTAL X-RAY FILM PROCESSORS |
Classification | Processor, Radiographic-film, Automatic, Dental |
Applicant | DENT-X CO. 250 CLEARBROOK RD. Elmsford, NY 10523 |
Contact | Donald R Hill |
Correspondent | Donald R Hill DENT-X CO. 250 CLEARBROOK RD. Elmsford, NY 10523 |
Product Code | EGY |
CFR Regulation Number | 892.1900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-09 |
Decision Date | 1987-11-06 |