ROEKO CALCIUM HYDROXIDE POINTS — Roeko USA, Inc. (510(k) K973539)
ROEKO CALCIUM HYDROXIDE POINTS — Roeko USA, Inc. (510(k) K973539) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: ROEKO CALCIUM HYDROXIDE POINTS; Applicant: Roeko USA, Inc.; Clearance track: 510(k).
| Device name | ROEKO CALCIUM HYDROXIDE POINTS |
|---|---|
| Applicant | Roeko USA, Inc. |
| Clearance track | 510(k) |
| Submission number | K973539 |
| Decision | Substantially Equivalent |
| Decision date | 1997-10-30 |
| Date received | 1997-09-18 |
| Product code | EJK |
| Device class | 2 |
| Medical specialty | Dental |
| Applicant location | MA, US |
| Source | openFDA device |
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$1999/mo
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