FDA 510(k) Applications Submitted by DANIEL MANELLI
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K992553 |
07/30/1999 |
IQ CHAMBERS |
DORMER LABORATORIES, INC. |
| K980058 |
01/06/1998 |
TOKUSO MAC BOND II |
TOKUYAMA AMERICA, INC. |
| K980051 |
01/06/1998 |
PALFIQUE ESTELITE PASTE |
TOKUYAMA AMERICA, INC. |
| K980054 |
01/06/1998 |
PALFIQUE ESTELITE |
TOKUYAMA AMERICA, INC. |
| K990044 |
01/06/1999 |
LOBOB UNIVERSAL CONTACT LENS CLEANER |
LOBOB LABORATORIES, INC. |
| K010267 |
01/29/2001 |
PALFIQUE ESTELITE LV CLEAR |
TOKUYAMA AMERICA, INC. |
| K961050 |
02/08/1996 |
RELIEFBAND TENS UNIT (MODIFICATION) |
MAVEN LABS, INC. |
| K030663 |
03/03/2003 |
TOKUYAMA SOFRELINER TOUGH |
TOKUYAMA DENTAL CORPORATION |
| K010692 |
03/08/2001 |
THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEM |
SPINTECH, INC. |
| K961005 |
03/12/1996 |
SARGON IMMEDIATE LOAD IMPLANT |
GRAHAM & JAMES |
| K050658 |
03/14/2005 |
RESO-PAC PERIODONTAL DRESSING |
HAGER WORLDWIDE, INC. |
| K990895 |
03/17/1999 |
OXYCON LENS |
CONCISE CONTACT LENS CO. |
| K981037 |
03/19/1998 |
CLEAR (TM) SPECIAL NIT COMB |
CARE TECHNOLOGIES, INC. |
| K981147 |
03/30/1998 |
CLEAR (TM) LICE EGG REMOVER SYSTEM |
CARE TECHNOLOGIES, INC. |
| K981141 |
03/30/1998 |
SARGON IMMEDIATE LOAD IMPLANT, MODEL D |
SARGON ENT., INC. |
| K961648 |
04/29/1996 |
THE WAND |
SPINTECH, INC. |
| K001428 |
05/05/2000 |
OPTIMUM WETTING AND REWETTING DROP |
LOBOB LABORATORIES, INC. |
| K001442 |
05/08/2000 |
ESU HANDSWITCHING PENCIL |
SURGEX, INC. |
| K991711 |
05/19/1999 |
BISTITE II SC |
TOKUYAMA AMERICA, INC. |
| K011685 |
05/31/2001 |
BISTITE II DC |
TOKUYAMA AMERICA, INC. |
| K011854 |
06/13/2001 |
TOKUYAMA M-BOND |
TOKUYAMA AMERICA, INC. |
| K001964 |
06/27/2000 |
OPTIMUM CLEANING, DISINFECTING AND STORAGE SOLUTION |
LOBOB LABORATORIES, INC. |
| K061904 |
07/05/2006 |
COMPUDENT STA |
MILESTONE SCIENTIFIC, INC. |
| DEN990005 |
07/12/1999 |
THE 3PM EGG MACHINE |
3PM CO., INC. |
| K992404 |
07/19/1999 |
THE WAND |
SPINTECH, INC. |
| K982537 |
07/21/1998 |
TOKUYAMA SOFRELINER |
TOKUYAMA AMERICA, INC. |
| K072064 |
07/27/2007 |
GRAVILAX TRACTION SYSTEM |
THERAPEUTIC CLINICAL TECHNOLOGIES, INC. |
| K953589 |
08/01/1995 |
TOKUYAMA SOFT RELINING |
TOKUYAMA AMERICA, INC. |
| K992582 |
08/02/1999 |
PACIFIC IMPLANT TITANIUM ENDODONTIC POINT |
PACIFIC IMPLANT, INC. |
| K022641 |
08/08/2002 |
TOKUYAMA REBASE II |
TOKUYAMA AMERICA, INC. |
| K992819 |
08/20/1999 |
WAND PLUS |
SPINTECH, INC. |
| K973245 |
08/29/1997 |
TOKUSO REBASE MR. BOND |
TOKUYAMA AMERICA, INC. |
| K082573 |
09/05/2008 |
SARGON NON-EXPANDABLE DENTAL IMPLANT |
SARGON ENT., INC. |
| K002863 |
09/13/2000 |
PALFIQUE ESTELITE LV |
TOKUYAMA AMERICA, INC. |
| K082800 |
09/24/2008 |
STAR/VENT INTERNAL HEX SCREW IMPLANT |
PARK DENTAL RESEARCH CORP. |
| K954593 |
10/03/1995 |
THE AIRCEL SYSTEM |
MARCON GROUP, INC. |
| K023722 |
11/05/2002 |
SAFETYWAND DISPOSABLE HANDPIECE |
SPINTECH, INC. |
| K063364 |
11/07/2006 |
ALPHA BIO DENTAL IMPLANT SYSTEM |
ALPHA-BIO TEC LTD |
| K993917 |
11/17/1999 |
TOKUYAMA ONE-UP-BOND F |
TOKUYAMA AMERICA, INC. |
| K014162 |
12/19/2001 |
MODIFICATION TO OPTIMUM CLEANING, DISINFECTING AND |
LOBOB LABORATORIES, INC. |
| K063770 |
12/20/2006 |
ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM |
ALPHA-BIO TEC LTD |
| K063769 |
12/20/2006 |
ALPHA BIO BONE FIXATION SCREW SYSTEM |
ALPHA-BIO TEC LTD |
|
|
