The following data is part of a premarket notification filed by Teledyne Water Pik with the FDA for Kalginate Impression Material.
| Device ID | K970594 |
| 510k Number | K970594 |
| Device Name: | KALGINATE IMPRESSION MATERIAL |
| Classification | Material, Impression |
| Applicant | TELEDYNE WATER PIK 1730 EAST PROSPECT RD. Fort Collins, CO 80525 -1310 |
| Contact | Michael J Ryan |
| Correspondent | Michael J Ryan TELEDYNE WATER PIK 1730 EAST PROSPECT RD. Fort Collins, CO 80525 -1310 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-18 |
| Decision Date | 1997-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D6860150239 | K970594 | 000 |
| D6860150219 | K970594 | 000 |
| D6860131261 | K970594 | 000 |
| D6860131139 | K970594 | 000 |
| D6860131129 | K970594 | 000 |
| D6860131119 | K970594 | 000 |