FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HANDPIECE FIBER OPTIC SYSTEM IMPROVEMENT FEATURE
K Number: K896361
·
Decision Feb 2, 1990
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
260
Applicant Total
13
Review Days
88
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Basic Information
- Device Name
- HANDPIECE FIBER OPTIC SYSTEM IMPROVEMENT FEATURE
- K Number
- K896361
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Dentalez Group
- Date Received
- November 6, 1989
- Decision Date
- February 2, 1990
- Product Code
- EFB
- 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 |
|---|---|---|---|
| EFB | Handpiece, Air-Powered, Dental | FDA class 1 | Dental |
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| K Number | Device Name | ||
|---|---|---|---|
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| 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 |