FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULL
K Number: K902645
·
Decision Sep 6, 1990
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
35
Applicant Total
40
Review Days
83
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
- HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULL
- K Number
- K902645
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5500
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Ormco Corp.
- Date Received
- June 15, 1990
- Decision Date
- September 6, 1990
- 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 Ormco Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K141611 | LYTHOS DIGITAL IMPRESSION SYSTEM | Dec 5, 2014 | Substantially Equivalent |
| K123118 | INSIGNIA DIGICAST | Mar 26, 2013 | Substantially Equivalent |
| K123416 | INSIGNIA WITH ITERO | Mar 13, 2013 | Substantially Equivalent |
| K122065 | DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE | Feb 8, 2013 | Substantially Equivalent |
| K121524 | INSIGNIA | Aug 9, 2012 | Substantially Equivalent |
| K112640 | HYPERELASTIC WIRE | Nov 16, 2011 | Substantially Equivalent |
| K101676 | CLEARARCH | Sep 13, 2010 | Substantially Equivalent |
| K081900 | TEMPORARY TOOTH REPLACEMENT | Oct 24, 2008 | Substantially Equivalent |
| K081415 | DAMON 4CLEAR | Sep 24, 2008 | Substantially Equivalent |
| K062856 | TF ROTARY NICKEL TITANIUM FILE | Dec 13, 2006 | Substantially Equivalent |