FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLASS III REVERSE PULL FACEMASK
K Number: K980436
·
Decision Apr 27, 1998
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
35
Applicant Total
7
Review Days
82
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CLASS III REVERSE PULL FACEMASK
- K Number
- K980436
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5500
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ortho Kinetics Corp.
- Date Received
- February 4, 1998
- Decision Date
- April 27, 1998
- Product Code
- DZB
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DZB | Headgear, Extraoral, Orthodontic | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DZB), ordered by most recent decision date.
Orthodontic Facemask
FDA 510(k)
FDA Class 2
·Dental
Reverse Pull Adjustable Facemask
FDA 510(k)
FDA Class 2
·Dental
PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF
FDA 510(k)
FDA Class 2
·Dental
KJ MASK
FDA 510(k)
FDA Class 2
·Dental
NITOM LOCKING FACEBOW
FDA 510(k)
FDA Class 2
·Dental
EQUA-PULL SAFETY RELEASE MODULE
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Ortho Kinetics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K982088 | AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM | Sep 4, 1998 | Substantially Equivalent |
| K980245 | NITOM LOCKING FACEBOW | Apr 21, 1998 | Substantially Equivalent |
| K980864 | POWER COINS GLOW IN THE DARK LIGATURES | Apr 20, 1998 | Substantially Equivalent |
| K980151 | RELEASABLE FORCE MODULE | Apr 6, 1998 | Substantially Equivalent |
| K980195 | FACEBOW | Mar 11, 1998 | Substantially Equivalent |
| K940410 | NEW GEAR RELEASABLE HEADGEAR | Mar 10, 1994 | Substantially Equivalent |