Reverse Pull Adjustable Facemask
FDA 510(k) clearance K162543 · decided 2017-08-28
Clearance details
- K-number
- K162543
- Device name
- Reverse Pull Adjustable Facemask
- Applicant
- Sawbros Industries Pvt., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2016-09-12
- Decision date
- 2017-08-28
- Days to decision
- 350 days
- Clearance type
- Traditional
- Product code
- DZB
- Device class
- 2
- Regulation number
- 872.5500
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Noida, IN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Orthodontic Facemask (K202855) | Ita.O Italian Orthodontic System S.R.L. | 2021-06-21 |
| PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF (K111169) | Kwang Myung Daicom, Inc. | 2011-10-03 |
| KJ MASK (K103019) | Kj Meditech Co., Ltd. | 2011-06-09 |
| NITOM LOCKING FACEBOW (K052553) | Russell Samuels Orthodontic Design | 2005-12-22 |
| EQUA-PULL SAFETY RELEASE MODULE (K051751) | Ortho Technology | 2005-07-22 |
| KELES FACEMASK (K041718) | Great Lakes Orthodontics, Ltd. | 2004-10-15 |
| MORALES PROTRACTION FACEMASK (K032392) | Ortosim, S.A. DE C.V. | 2003-10-22 |
| MULTI ADJUSTABLE FACE MASK (K000358) | Ortho Technology | 2000-06-09 |
| T-GEAR, MODEL TG/400-700 (K993224) | Dontech Products B.V. | 2000-02-11 |
| AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM (K982088) | Ortho Kinetics Corp. | 1998-09-04 |
| CLASS III REVERSE PULL FACEMASK (K980436) | Ortho Kinetics Corp. | 1998-04-27 |
| NITOM LOCKING FACEBOW (K980245) | Ortho Kinetics Corp. | 1998-04-21 |
Recalls involving this device
No recalls on record reference this clearance.