The following data is part of a premarket notification filed by Sirona Dental Systems Gmbh with the FDA for Modification To Sidexis Digital Radiography Imaging System.
Device ID | K013659 |
510k Number | K013659 |
Device Name: | MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM |
Classification | System, X-ray, Extraoral Source, Digital |
Applicant | SIRONA DENTAL SYSTEMS GMBH 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
Contact | Sheila Hemeon-heyer |
Correspondent | Sheila Hemeon-heyer SIRONA DENTAL SYSTEMS GMBH 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
Product Code | MUH |
CFR Regulation Number | 872.1800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-11-06 |
Decision Date | 2001-12-06 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
E27662291290 | K013659 | 000 |