| STATUSBLUE (K013237) | Dmg USA, Inc. | 2001-10-22 |
| ICE (K012528) | Southern Dental Industries, Ltd. | 2001-10-22 |
| ROK (K012529) | Southern Dental Industries, Ltd. | 2001-10-22 |
| ASTRALIS 10, MODELS # 559588, 561859 (K013275) | Ivoclar Vivadent, Inc. | 2001-10-19 |
| LUXABITE (K013236) | Dmg USA, Inc. | 2001-10-17 |
| REVOTEK LC (K012542) | GC America, Inc. | 2001-10-16 |
| MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE (K013176) | Afp Imaging Corp. | 2001-10-16 |
| LUXAGLAZE (K013179) | Dmg USA, Inc. | 2001-10-12 |
| RHODIA DENTAL PUTTY IMPRESSION MATERIAL (K013129) | Rhodia, Inc. | 2001-10-10 |
| SNOWPOST, SNOWLIGHT (K012354) | Danville Materials, Inc. | 2001-10-10 |
| RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL (K013140) | Rhodia, Inc. | 2001-10-10 |
| PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT (K012427) | Specialites Septodont | 2001-10-09 |
| W & H ASSISTINA (K010127) | A-Dec, Inc. | 2001-10-05 |
| SOPRO595 INTRA ORAL CAMERA (K012505) | Sopro | 2001-10-05 |
| INION CPS 2.0 ORTHOGNATHIC PLATE (K013039) | Inion , Ltd. | 2001-10-05 |
| THE QUIET SLEEPER (K012142) | Precision Dental Laboratories, Inc. | 2001-10-04 |
| BELLEGLASS HP DC OPACEOUS DENTIN LCTE 2 (K013009) | Sybron Dental Specialties, Inc. | 2001-10-03 |
| NEXUS 2 MODIFIED (K013008) | Sybron Dental Specialties, Inc. | 2001-10-02 |
| SUNLITELED MODEL #2810 (K012946) | Kinetic Instruments, Inc. | 2001-10-02 |
| CYTOFLEX (K012144) | Unicare Biomedical, Inc. | 2001-10-01 |
| SONICWAVE SONIC PLAQUE REMOVER (K012914) | Homedics, Inc. | 2001-10-01 |
| BELLEGLASS HP ENAMEL 2 (K013007) | Sybron Dental Specialties, Inc. | 2001-10-01 |
| UCLA AND UNIVERSAL ABUTMENTS (K010619) | Diamodent | 2001-09-28 |
| UNIVERSAL DENTAL COPING (UDC) (K010467) | Paxmed International | 2001-09-28 |
| UNIPLANT DENTAL IMPLANT SYSTEM (K011574) | Universal Implant Systems, Inc. | 2001-09-28 |
| MIS IMPLANT SYSTEM DECIVE (K003191) | Mis Implants Technologies , Ltd. | 2001-09-28 |
| BLUE SKY BIO DENTAL IMPLANT SYSTEM (K010882) | Blue Sky Bio | 2001-09-28 |
| OMNICARE DENTAL IMPLANT SYSTEM (K000035) | Omnicare Dental Implant Center | 2001-09-28 |
| 3I LOCATER ABUTMENT SYSTEM (K012911) | Implant Innovations, Inc. | 2001-09-28 |
| COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408 (K012160) | Premier Dental Products Co. | 2001-09-27 |
| QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM (K002241) | Quantum Bioengineering, Ltd. | 2001-09-20 |
| QUANTUM VERSATILITY IMPLANT SYSTEM (K991250) | Quantum Bioengineering, Ltd. | 2001-09-20 |
| OPTIBOND SOLO PLUS ACTIVATOR (K012082) | Sybron Dental Specialties, Inc. | 2001-09-20 |
| QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM (K011223) | Paxmed International | 2001-09-20 |
| NSI HEXED AND NON-HEXED IMPLANT SYSTEM (K003620) | Nsi | 2001-09-19 |
| 3I CALCIUM SULFATE BONE CEMENT (K012047) | Implant Innovations, Inc. | 2001-09-19 |
| MACROPORE FX, PS, NS, LP (K012413) | Macropore Biosurgery, Inc. | 2001-09-18 |
| FIRST SPEP (K012032) | Bisco, Inc. | 2001-09-17 |
| CHROMA ZONE COLOR STAIN (K012737) | Kuraray Medical, Inc. | 2001-09-14 |
| CLEARFIL DC CEMENT (K012735) | Kuraray Medical, Inc. | 2001-09-14 |
| CLEARFIL AP-X (K012740) | Kuraray Medical, Inc. | 2001-09-14 |
| TEETHMATE F-1 (K012742) | Kuraray Medical, Inc. | 2001-09-14 |
| VERTEX ETCHANT (K010849) | Apex Dental Materials, Inc. | 2001-09-14 |
| CARIES DETECTOR (K012733) | Kuraray Medical, Inc. | 2001-09-14 |
| CLEARFIL NEW BOND (K012734) | Kuraray Medical, Inc. | 2001-09-14 |
| OTO-CEM (K011338) | Ototech, Inc. | 2001-09-13 |
| CLEARFIL PORCELAIN BOND ACTIVATOR (K012730) | Kuraray Medical, Inc. | 2001-09-13 |
| CLEARFIL REPAIR (K012729) | Kuraray Medical, Inc. | 2001-09-13 |
| ESTENIA (K012707) | Kuraray Medical, Inc. | 2001-09-13 |
| ELEC-MATE E (K011926) | Nakanishi, Inc. | 2001-09-11 |
| SURGIPLASTER CALCIUM SULFATE HEMIHYDRATE (K011403) | Orthogen Corp. | 2001-09-11 |
| CLEARFIL PHOTO CORE (K012705) | Kuraray Medical, Inc. | 2001-09-11 |
| CLEARFIL ST OPAQUER (K012704) | Kuraray Medical, Inc. | 2001-09-10 |
| CLEARFIL CORE NEW BOND (K012703) | Kuraray Medical, Inc. | 2001-09-10 |
| MODIFICATION TO CLEARFIL SE BOND (K012442) | Kuraray Medical, Inc. | 2001-09-10 |
| PANAVIA F (K012441) | Kuraray Medical, Inc. | 2001-09-06 |
| 3.25MM SPLINE TWIST IMPLANT (K012055) | Sulzer Dental, Inc. | 2001-09-06 |
| OPTIBOND SOLO PLUS 3 (K011908) | Kerr Dental Materials Center | 2001-09-06 |
| LC TEMPORARY FILLING (K012360) | Parkell, Inc. | 2001-09-06 |
| BRITESMILE BARRIER MATERIAL (K010935) | Britesmile, Inc. | 2001-09-05 |
| A-WEAR (K012180) | Bisco, Inc. | 2001-09-05 |
| DENTORIUM CONVERTIBLE ACRYLIC (K011820) | Nats Corp. | 2001-09-05 |
| MODIFICATION TO PANAVIA 21 (K012438) | Kuraray Medical, Inc. | 2001-09-05 |
| MODIFICATION TO CLEARFIL LINER BOND 2V (K012440) | Kuraray Medical, Inc. | 2001-09-05 |
| EXTRUDE MODIFIED (K012405) | Sybron Dental Specialties, Inc. | 2001-09-04 |
| MODIFICATION TO CLEARFIL PHOTO BOND (K012432) | Kuraray Medical, Inc. | 2001-09-04 |
| DC - CRISTAL (K011674) | Austenal, Inc. | 2001-09-04 |
| TOKUYAMA M-BOND (K011854) | Tokuyama America, Inc. | 2001-09-04 |
| NOVEL PRINT CYAN ALGINATES (K011785) | Manufacturera Dental Continental | 2001-09-04 |
| MODIFICATION TO ALLOY PRIMER (K012436) | Kuraray Medical, Inc. | 2001-09-04 |
| OPTIBOND 2 (K012322) | Sybron Dental Specialties, Inc. | 2001-08-30 |
| TRANSLUX ENERGY (K012341) | Heraeus Kulzer, Inc. | 2001-08-30 |
| GPW-SF (K011659) | Gateway Alloys, Inc. | 2001-08-27 |
| ERIS LAYERING MATERIALS (K012174) | Ivoclar North America, Inc. | 2001-08-27 |
| CONCORD 88 (K011661) | Gateway Alloys, Inc. | 2001-08-27 |
| POINT 4 FLOWABLE (K012321) | Sybron Dental Specialties, Inc. | 2001-08-27 |
| HI-WAVE; POUR-PLUS (K011762) | Denplus, Inc. | 2001-08-23 |
| LUXACORE/LUXACORE DUAL (K012307) | Dmg USA, Inc. | 2001-08-23 |
| PERMACEM / PERMACEM DUAL (K012316) | Dmg USA, Inc. | 2001-08-23 |
| STRAUMANN GBR SYSTEM (K011698) | Institut Straumann AG | 2001-08-23 |
| AVANTE MICRO CRYSTAL SYSTEM (K012231) | Jeneric/Pentron, Inc. | 2001-08-23 |
| JEL-20 (K012303) | J.F. Jelenko & Co., Inc. | 2001-08-22 |
| ITI DENTAL IMPLANT SYSTEM (K012757) | Straumann USA | 2001-08-22 |
| CERCON CERAM (K011333) | Degussa - Ney Dental, Inc. | 2001-08-20 |
| ITI DENTAL IMPLANT SYSTEM (K003552) | Institut Straumann SA | 2001-08-17 |
| FUTURA TOPCAP NON GAMMA-2 (K011801) | Ab Ardent | 2001-08-16 |
| HELIOSEAL CLEAR CHROMA (K011491) | Ivoclar North America, Inc. | 2001-08-16 |
| VERTEX SEALAND L/C ORTHODONTIC SEALANT (K010547) | Apex Dental Materials, Inc. | 2001-08-16 |
| IMAGINE H.E. (K012156) | Wieland Edelmetalle GmbH & Co. | 2001-08-16 |
| ALLFIT IMPLANT SYSTEM, SHORT NECK, MODEL STI RT LENGTH, ALLFIT IMPLANT SYSTEM, LONG NECK, MODEL STI RT LN LENGTH (K991822) | Dr. Ihde Dental AG Switzerland | 2001-08-15 |
| NORMED MANDIBULAR FIXATION SYSTEM (K010118) | Osteomedics, Inc. | 2001-08-14 |
| CORERESTORE 2 (K011798) | Sybron Dental Specialties, Inc. | 2001-08-14 |
| GULLIVER AND CLASSE A (K012213) | American Dental Technologies, Inc. | 2001-08-13 |
| DIGORA PCT (K012170) | Soredex Palodex Group OY | 2001-08-10 |
| VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE (K010544) | Apex Dental Materials, Inc. | 2001-08-10 |
| IMAGE-X SYSTEM (K012355) | Tg Group, Inc. | 2001-08-09 |
| OSSTELL RESONANCE FREQUENCY ANALYZER (K003714) | Integration Diagnostics, Ltd. | 2001-08-09 |
| LACTOSORB RAPIDFLAP (K003281) | Biomet, Inc. | 2001-08-07 |
| COLLAGEN DENTAL MEMBRANE (K011695) | Collagen Matrix, Inc. | 2001-08-07 |
| PIT AND FISSURE CHEMICAL CURING SEALANT (K011822) | Rite-Dent Manufacturing Corp. | 2001-08-07 |