The following data is part of a premarket notification filed by Kavo Dental Technologies, Llc with the FDA for Dexis Titanium, Kavo Ixs Hd (size 1, Size 2).
| Device ID | K172918 |
| 510k Number | K172918 |
| Device Name: | DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | KaVo Dental Technologies, LLC 11727 Fruehauf Drive Charlotte, NC 28273 |
| Contact | Frank Ray |
| Correspondent | Frank Ray KaVo Dental Technologies, LLC 11727 Fruehauf Drive Charlotte, NC 28273 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-25 |
| Decision Date | 2017-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D090101261800 | K172918 | 000 |
| D090101397180 | K172918 | 000 |
| D090101397190 | K172918 | 000 |
| D090101397200 | K172918 | 000 |
| D090101397210 | K172918 | 000 |
| D090101397220 | K172918 | 000 |
| D090101397230 | K172918 | 000 |
| D090101452070 | K172918 | 000 |
| D090101452090 | K172918 | 000 |
| D090101452100 | K172918 | 000 |
| D090101461040 | K172918 | 000 |
| D090101397170 | K172918 | 000 |
| D090101397160 | K172918 | 000 |
| D090101261810 | K172918 | 000 |
| D090101261820 | K172918 | 000 |
| D090101329130 | K172918 | 000 |
| D090101329150 | K172918 | 000 |
| D090101329450 | K172918 | 000 |
| D090101329490 | K172918 | 000 |
| D090101329500 | K172918 | 000 |
| D090101329510 | K172918 | 000 |
| D090101370490 | K172918 | 000 |
| D090101375650 | K172918 | 000 |
| D090101461050 | K172918 | 000 |
| EKAV101261800 | K172918 | 000 |
| EKAV101397180 | K172918 | 000 |
| EKAV101397190 | K172918 | 000 |
| EKAV101397200 | K172918 | 000 |
| EKAV101397210 | K172918 | 000 |
| EKAV101397220 | K172918 | 000 |
| EKAV101397230 | K172918 | 000 |
| EKAV101452070 | K172918 | 000 |
| EKAV101452090 | K172918 | 000 |
| EKAV101452100 | K172918 | 000 |
| EKAV101461040 | K172918 | 000 |
| EKAV101397170 | K172918 | 000 |
| EKAV101397160 | K172918 | 000 |
| EKAV101261810 | K172918 | 000 |
| EKAV101261820 | K172918 | 000 |
| EKAV101329130 | K172918 | 000 |
| EKAV101329150 | K172918 | 000 |
| EKAV101329450 | K172918 | 000 |
| EKAV101329490 | K172918 | 000 |
| EKAV101329500 | K172918 | 000 |
| EKAV101329510 | K172918 | 000 |
| EKAV101370490 | K172918 | 000 |
| EKAV101375650 | K172918 | 000 |
| EKAV101461050 | K172918 | 000 |