FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS
K Number: K983574
·
Decision Jan 8, 1999
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
72
Applicant Total
13
Review Days
87
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Basic Information
- Device Name
- STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS
- K Number
- K983574
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dentalez Group
- Date Received
- October 13, 1998
- Decision Date
- January 8, 1999
- Product Code
- EGS
- 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 |
|---|---|---|---|
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | FDA class 1 | Dental |
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| 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 |
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| K990844 | STARDENTAL AXCS STERILE WATER SYSTEM | May 28, 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 |
| K902402 | HIGH SPEED NON-FIBER OPTIC SWIVEL HANDPIECE | Aug 29, 1990 | Substantially Equivalent |