FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HIGH SPEED NON-FIBER OPTIC SWIVEL HANDPIECE
K Number: K902402
·
Decision Aug 29, 1990
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
13
Review Days
90
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
- HIGH SPEED NON-FIBER OPTIC SWIVEL HANDPIECE
- K Number
- K902402
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Dentalez Group
- Date Received
- May 31, 1990
- Decision Date
- August 29, 1990
- Product Code
- EBF
- 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EBF), ordered by most recent decision date.
SRGC-06
FDA 510(k)
FDA Class 2
·Dental
DIAFIL
FDA 510(k)
FDA Class 2
·Dental
DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)
FDA 510(k)
FDA Class 2
·Dental
Dual Core
FDA 510(k)
FDA Class 2
·Dental
Dura-Crown
FDA 510(k)
FDA Class 2
·Dental
Grandio disc multicolor
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Dentalez Group
| K Number | Device Name | ||
|---|---|---|---|
| K030133 | SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE SOLARA PLUS HIGH SPEED DENTAL HANDPIECE | Apr 29, 2003 | Substantially Equivalent |
| K021378 | PORTABLE HDX INTRAORAL X-RAY | Jun 7, 2002 | Substantially Equivalent |
| K990844 | STARDENTAL AXCS STERILE WATER SYSTEM | May 28, 1999 | Substantially Equivalent |
| K983574 | STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS | Jan 8, 1999 | Substantially Equivalent |
| K982593 | LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH SPEED DENTAL HANDPIE | Oct 22, 1998 | Substantially Equivalent |
| K960719 | STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE | Mar 28, 1996 | Substantially Equivalent |
| K960507 | STAR DENTAL PUSHBUTTON AUTOCHUCK REPLACEMENT TURBINE FOR MIDWEST HANDPIECES | Mar 28, 1996 | Substantially Equivalent |
| K960260 | STAR TITAN SERIES MOTORS & ATTACHMENTS | Mar 28, 1996 | Substantially Equivalent |
| K925567 | E 4000 DENTAL OPERATING CHAIR | Mar 10, 1994 | Substantially Equivalent |
| K931093 | QUICK-CONNECT 360 SWIVEL TIP AUTOCLAVABLE SYRINGE | Jan 21, 1994 | Substantially Equivalent |