The following data is part of a premarket notification filed by Ortek Therapeutics, Inc. with the FDA for Electronic Caries Detector.
| Device ID | K170822 |
| 510k Number | K170822 |
| Device Name: | Electronic Caries Detector |
| Classification | Laser, Fluorescence Caries Detection |
| Applicant | Ortek Therapeutics, Inc. 4 Expressway Plaza Roslyn Heights, NY 11577 |
| Contact | Mitchell Goldberg |
| Correspondent | Allison Komiyama AcKnowledge Regulatory Strategies 2834 Hawthorn St. San Diego, CA 92104 |
| Product Code | NBL |
| CFR Regulation Number | 872.1745 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-20 |
| Decision Date | 2017-09-11 |
| Summary: | summary |