OSSEODENT DRILLING SYSTEM
FDA 510(k) clearance K862110 · decided 1986-08-07
Clearance details
- K-number
- K862110
- Device name
- OSSEODENT DRILLING SYSTEM
- Applicant
- Otc/America
- Decision
- Substantially Equivalent
- Date received
- 1986-06-03
- Decision date
- 1986-08-07
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- KMW
- Device class
- 2
- Regulation number
- 872.4120
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Wellesley Hills, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Otc/America
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 |
|---|---|---|
| Oral Surgery Contra (K211584) | Nakanishi, Inc. | 2021-08-19 |
| Surgical Angle Handpiece, Surgical Straight Handpiece (K171155) | Nakanishi, Inc. | 2017-11-21 |
| OsteoMed PINNACLE Driver (K162544) | Osteomed | 2017-04-04 |
| SURGICAL HANDPIECES, MIKRO SAW HANDPIECES (K080939) | W&H Dentalwerk Buermoos GmbH | 2008-07-29 |
| FRIOS MICROSAW (K994298) | Friadent GmbH | 2000-02-18 |
| OSTEOPOWER SYSTEM AND ACCESSORIES (K971692) | Osteomed Corp. | 1997-06-27 |
| E-TYPE SPEED REDUCER CONTRA ANGLE (K970953) | Nsk Nakanishi, Inc. | 1997-04-15 |
| YOUNG D'GRANULATOR (K932255) | Young Dental Manufacturing Co. 1, LLC | 1994-04-15 |
Recalls involving this device
No recalls on record reference this clearance.