The following data is part of a premarket notification filed by Roeko Usa, Inc. with the FDA for Roeko Calcium Hydroxide Points.
| Device ID | K973539 |
| 510k Number | K973539 |
| Device Name: | ROEKO CALCIUM HYDROXIDE POINTS |
| Classification | Liner, Cavity, Calcium Hydroxide |
| Applicant | ROEKO USA, INC. 100 MAIN STREET,STE. 120 Concord, MA 01742 |
| Contact | James Delaney |
| Correspondent | James Delaney ROEKO USA, INC. 100 MAIN STREET,STE. 120 Concord, MA 01742 |
| Product Code | EJK |
| CFR Regulation Number | 872.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-18 |
| Decision Date | 1997-10-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E16555330 | K973539 | 000 |
| E1653668201 | K973539 | 000 |
| E1653668251 | K973539 | 000 |
| E1653668301 | K973539 | 000 |
| E1653668351 | K973539 | 000 |
| E1653668401 | K973539 | 000 |
| E1653668451 | K973539 | 000 |
| E1653668501 | K973539 | 000 |
| E1653668551 | K973539 | 000 |
| E1653668601 | K973539 | 000 |
| E1653668701 | K973539 | 000 |
| E1653668801 | K973539 | 000 |
| E1653668960 | K973539 | 000 |
| E1653668970 | K973539 | 000 |
| E1653668151 | K973539 | 000 |