PROCEM
FDA 510(k) clearance K140644 · decided 2014-06-19
Clearance details
- K-number
- K140644
- Device name
- PROCEM
- Applicant
- Ototronix, LLC
- Decision
- Substantially Equivalent
- Date received
- 2014-03-13
- Decision date
- 2014-06-19
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- NEA
- Device class
- 2
- Regulation number
- 872.3275
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ototronix
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ENVOYCEM, MODEL 1640 (K080032) | Envoy Medical Corporation | 2008-02-28 |
| STRYKER INJECTABLE CEMENT (K060750) | Stryker Cmf | 2006-04-19 |
| OTOMIMIX (K042516) | Walter Lorenz Surgical, Inc. | 2004-11-08 |
| OTO-CEM (K011338) | Ototech, Inc. | 2001-09-13 |
| SERENOCEM, MODEL BC 010 (K003567) | Corinthian Medical , Ltd. | 2001-02-12 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MAXUM System (P010023/S014) | Ototronix, LLC | 2020-10-28 |
| MAXUM SYSTEM (P010023/S012) | Ototronix, LLC | 2016-05-03 |
| SOUNDTECH DIRECT AND MAXUM (P010023/S013) | Ototronix, LLC | 2016-03-22 |
| MAXUM (P010023/S011) | Ototronix, LLC | 2015-05-04 |
| MAXUM (P010023/S010) | Ototronix, LLC | 2013-09-13 |
| MAXUM SYSTEM (P010023/S007) | Ototronix, LLC | 2012-05-10 |
| MAXUM SYSTEM (P010023/S009) | Ototronix, LLC | 2011-07-15 |
| MAXUM SYSTEM (P010023/S004) | Ototronix, LLC | 2011-04-08 |