The following data is part of a premarket notification filed by Rounding Third Llc with the FDA for Step-1 Pumetch.
| Device ID | K213093 |
| 510k Number | K213093 |
| Device Name: | STEP-1 PumEtch |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | Rounding Third LLC 9750 East Easter Avenue #155 Centennial, CO 80112 |
| Contact | Thomas Macari |
| Correspondent | Adrienne Von Foller QRS Solutions LLC 966 E. 2050 N North Ogden, UT 84414 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-24 |
| Decision Date | 2022-01-28 |