meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
24
Latest Decision
1995-10-31

Clearances · page 82 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K953000 WIDE SYSTEM SCREW B5 UNCOATED 5MM, 6MM Implant Center of the Palm Beaches DZE Class II 1995-10-31
K952999 UNCOATED SCREW IMPLANT 3.75, 4.0-B5 Implant Center of the Palm Beaches DZE Class II 1995-10-31
K952996 HA/TP COATED CYLINDER IMPLANT 3.3,4.0 Implant Center of the Palm Beaches DZE Class II 1995-10-31
K952992 PROSTHETICS 4MM Implant Center of the Palm Beaches DZE Class II 1995-10-31
K952991 WIDE SCREW HA-5B, CYL-HA-5 Implant Center of the Palm Beaches DZE Class II 1995-10-31
K954539 LG HEX PROSTHETICS The Implant Center of the Palm Beaches DZE Class II 1995-10-30
K954406 AMERICAN DENTAL PRODUCTS COMPOSITE RESIN CORE PASTE WITH FLUORIDE American Dental Products, Inc. EBF Class II 1995-10-30
K954530 THE SILENCER Silent Knights Ventures, Inc. LRK Class II 1995-10-30
K954708 SILANE PRIMER Sybron Dental Specialties, Inc. KLE Class II 1995-10-30
K954405 AMERICAN DENTAL PRODDUCTS LIGHT ACTIVATED COMPOSITE RESIN CORE PASTE WITH FLUORIDE American Dental Products, Inc. EBF Class II 1995-10-30
K954408 AMERICAN DENTAL PRODUCTS LIGHT ACTIVATED COMPOSITE RESIN CORE BUILDUP BLUE PASTEE American Dental Products, Inc. EBF Class II 1995-10-30
K954689 CONNECT Sybron Dental Specialties, Inc. EBI Class II 1995-10-30
K954133 AMERICAN DENTAL PRODUCTS WETTING AGENT & DESENSITIZER American Dental Products, Inc. KLE Class II 1995-10-30
K954702 IMPLANTALOY Metalor Dental USA Corp. EJT Class II 1995-10-30
K954407 AMERICAN DENTAL PRODUCTS WHITE COMPOSITE RESIN CORE PASTE WITH FLUORIDE American Dental Products, Inc. EBF Class II 1995-10-30
K954701 AMERICAN DENTAL PRODUCTS PIT & FISSUE SEALANT LIGHT CURING American Dental Products, Inc. EBC Class II 1995-10-30
K954565 EXPLOR-X (AZTEH) HF Chicago X-Ray Systems, Inc. EAP Class II 1995-10-27
K952628 ROYAL SHIELD NON-STERILE POWDER-FREE RUBBER DAMS Elastomade Accessories Sdn Bhd EIE Class I 1995-10-19
K954374 AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE, TWO PASTE BONDING SYSTEM American Dental Products, Inc. DYH Class II 1995-10-19
K954643 TRY-IN GEL Sybron Dental Specialties, Inc. EMA Class II 1995-10-19
K954373 AMERICAN DENTAL PRODUCTS PASTE-PRIMER ADHESIVE ORTHODONTIC BONDING SYSTEM W/FLUORIDE American Dental Products, Inc. DYH Class II 1995-10-19
K954372 AMERICAN DENTAL PRODUCTS TWO PASTE ADHESIVE ORTHODONTIC BONDING SYSTEM W/FLUORIDE American Dental Products, Inc. DYH Class II 1995-10-17
K935892 INDURENT GEL Zhermack Dental Production ELW Class II 1995-10-17
K954324 SNOR-X MOUTH GUARD Snorex, Inc. LRK Class II 1995-10-17
K952917 STERI-OSS IMMEDIATE PLACEMENT IMPLANT Steri-Oss, Inc. DZE Class II 1995-10-16
K954461 AMERICAN DENTAL PRODUCTS CORE BUILDUP PASTE American Dental Products, Inc. EBF Class II 1995-10-16
K954362 ARGISTAR 74 Argen Precious Metals, Inc. EJT Class II 1995-10-12
K954333 AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE W/ONE STEP BONDING SYSTEM American Dental Products, Inc. DYH Class II 1995-10-12
K954244 AMERICAN DENTAL PRODUCTS LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM W/FLUORIDE American Dental Products, Inc. DYH Class II 1995-10-12
K954358 ARGENDENT GIO 86 FR Argen Precious Metals, Inc. EJT Class II 1995-10-07
K954368 ARGEDENT BIO 87 PF Argen Precious Metals, Inc. EJT Class II 1995-10-07
K952763 PANORAMIC X-RAY UNIT (MODIFICATION) Planmeca Oy EHD Class II 1995-10-07
K953919 DENTAL ULTRASONIC SCALER INSERTS Hu-Friedy Mfg. Co., Inc. ELC Class II 1995-10-07
K954371 SUREFIRE S Argen Precious Metals, Inc. EJT Class II 1995-10-07
K954359 SILFREE 80SF+ Argen Precious Metals, Inc. EJT Class II 1995-10-07
K954367 ARGISTAR BIO 75PF Argen Precious Metals, Inc. EJT Class II 1995-10-07
K954361 ARGENCO 68M Argen Precious Metals, Inc. EJT Class II 1995-10-07
K954404 AUROLITE 45 Argen Precious Metals, Inc. EJT Class II 1995-10-07
K954360 ARGESOL 600 Argen Precious Metals, Inc. EJT Class II 1995-10-07
K944718 W&H 900 INCOLIGHT LT HANDPIECE A-Dec, Inc. EFB Class I 1995-10-05
K944719 W&H 100 SERIES LOW SPEED A-Dec, Inc. EFB Class I 1995-10-05
K945734 W&H ROTO QUICK COUPLINGS A-Dec, Inc. EFB Class I 1995-10-05
K953158 HAWN UNIVERSAL Metal-Tech DZE Class II 1995-10-05
K953613 IMPERVA ENSURABOND Shofu Dental Corp. KLE Class II 1995-10-04
K946311 INTEGRAL VII 3.25MM BIOINTEGRATED DENTAL IMPLANT SYSTEM Calcitek, Inc. DZE Class II 1995-10-04
K953612 IMPERVA FLUOROBOND Shofu Dental Corp. KLE Class II 1995-10-04
K953435 BRANEMARK RADIOGRAPHIC DEPTH GUAGE Nobelpharma USA, Inc. DZE Class II 1995-10-03
K953504 MICROPRIME Danville Engineering, Inc. KLE Class II 1995-10-03
K953743 PALASPLINT Heraeus Kulzer, Inc. EBI Class II 1995-10-02
K953812 GAUZE SPONGE Remington Medical, Inc. KHR Class I 1995-10-02
K954128 SNOREMASTER D.D.S., Inc. LRK Class II 1995-10-02
K954223 AMERICAN DENTAL PRODUCTS ALGINATE FLAVORING American Dental Products, Inc. ELW Class II 1995-09-29
K953273 BIOPLATE RIGID FIXATION BONE PLATING SYSTEM Biomedics JEY Class II 1995-09-29
K942139 SUPRASSON P MAX Satelec ELC Class II 1995-09-29
K952728 RETRAC Centrix, Inc. ELW Class II 1995-09-29
K953628 PROPHY ANGLE Rolence Enterprise Co. , Ltd. EHK Class I 1995-09-29
K953604 SHAPING HEDSTROM N.T. Sybron Dental Specialties, Inc. EKS Class I 1995-09-28
K953385 LORENZ 1.0MM, 1.5MM, 2.0MM SYSTEM Walter Lorenz Surgical, Inc. JEY Class II 1995-09-28
K926371 ANGLED 3.25 MM DENTAL IMPLANT ATTACHMENTS International Implant Seminars DZE Class II 1995-09-27
K953381 PROP. CONQUEST C&B VLC GLAZE/SEALANT Jeneric/Pentron, Inc. EBI Class II 1995-09-27
K954115 ARTGLASS & KEVLOC Heraeus Kulzer, Inc. EBF Class II 1995-09-27
K954177 ALPHA-BOND DENTIN BONDING SYSTEM Alpha-Bond, Inc. EMA Class II 1995-09-27
K953774 BRANEMARK RESTORATIVE INSTRUMENT & COMPONENT TRAY Nobelpharma USA, Inc. DZE Class II 1995-09-27
K950204 3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS, MINIPLANTS (TM) Implant Innovations, Inc. DZE Class II 1995-09-27
K953166 FUJI BOND LC GC America, Inc. KLE Class II 1995-09-27
K953405 HEMA-BENZ Health-Dent Intl., Inc. KLE Class II 1995-09-27
K944225 DUAL INTEGRATOR DENTAL IMPLANT Implant Integration Systems, Inc. DZE Class II 1995-09-27
K953476 MULTI-PRIME AKA/MONO-PRIME Silicon-Und Composite Spezialitaten GmbH KLE Class II 1995-09-22
K926367 PHOENIX 3.25 MM HA COATED DENTAL IMPLANT International Implant Seminars DZE Class II 1995-09-21
K943180 INTEGRAL IV BIOINTEGRATED DENTAL IMPLANT SYSTEM Calcitek, Inc. DZE Class II 1995-09-21
K926366 PHOENIX 3.25 MM C.P. COATED DENTAL IMPLANT International Implant Seminars DZE Class II 1995-09-21
K953775 BRANDEMARK ACCESSORIES TO CERAMIC ABUTYMENT (CERAMICORE) Nobelpharma USA, Inc. DZE Class II 1995-09-21
K952592 OPTI-MAX INTERNAL-HEX ANGLED IMPLANT CROWN POST, 10 DEGREE & 20 DEGREE INCLINATIONS Opti-Max DZE Class II 1995-09-21
K953836 ABUTMENT Steri-Oss, Inc. DZE Class II 1995-09-21
K926370 STRAIGHT 3.25 MM DENTAL IMPLANT ATTACHMENTS International Implant Seminars DZE Class II 1995-09-21
K926311 PHOENIX 4.0 MM ANGLED DENTAL ATTACHMENTS Vancouver Implant Center DZE Class II 1995-09-21
K926309 PHOENIX 4.0 MM DENTAL IMPLANT Vancouver Implant Center DZE Class II 1995-09-21
K945500 WELLS JOHNSON FIXATION SYSTEM Wells Johnson Co. JEY Class II 1995-09-21
K952218 JT-3 ELECTROGNATHOGRAPH Bio-Research Associates, Inc. NFS Class I 1995-09-21
K954061 POLY-LITE MODEL 1000 Pro-Den Systems, Inc. EBZ Class II 1995-09-21
K951074 STOMAVISION (STV) Trophy Radiologie EIA Class I 1995-09-19
K952634 OPTI-MAX EXTERNALLY THREADED EXTERNAL-HEX DENTAL IMPLANT, TITANIUM PLASMA-SPRAY COATED, WITH HEALING SCREW Opti-Max DZE Class II 1995-09-18
K952886 BRANEMARK SYSTEM OVOID & U-SHAPED BAR SYSTEM Nobelpharma USA, Inc. DZE Class II 1995-09-18
K952685 BRANEMARK SYSTEM DRILLS AND COUNTERSINKS Nobelpharma USA, Inc. DZE Class II 1995-09-18
K950066 DENTAL IMPLANT ENDOSSEOUS O Co., Inc. DZE Class II 1995-09-15
K953293 PM POSITIONER Jonathan A. Parker, D.D.S. LQZ Class II 1995-09-15
K953386 9I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: BONE MESH-PLATE & SCREWS Implant Innovations, Inc. JEY Class II 1995-09-15
K953281 HA, TP CYLINDER OVAL Implant Center of the Palm Beaches DZE Class II 1995-09-15
K953280 HA, TP CYLINDER, UNIHOLE Implant Center of the Palm Beaches DZE Class II 1995-09-15
K953237 PROSTHETICS & INSTRUMENTATION A. PROSTHETIC ABUTMENTS 4, 5, 6 DIAMETER, GRADE 3, B. IRRIGATION DRILLS, TOOLING & PREANG' The Implant Center of the Palm Beaches DZE Class II 1995-09-15
K953236 CYLINDER IMPLANTS HA, TP, GRADE 3 The Implant Center of the Palm Beaches DZE Class II 1995-09-13
K953235 SCREW IMPLANTS, GRADE 3; UNCOATED, HA, TP-K3 The Implant Center of the Palm Beaches DZE Class II 1995-09-13
K953139 KIS-- FOUR HOLE CYLINDER Implant Center of the Palm Beaches DZE Class II 1995-09-13
K952856 LIGHT-CURE PC Midwest Orthodontic Mfg. DYH Class II 1995-09-12
K952930 DENTRAY II PLUS TRAY ADHESIVE Confi-Dental Products Co. ELW Class II 1995-09-08
K952855 PC-LOCK Midwest Orthodontic Mfg. DYH Class II 1995-09-08
K935890 ZETAPLUS (PUTTY) Zhermack Dental Production ELW Class II 1995-09-08
K953168 ULTRACID F DISINFECTING SOLUTION Ultradent Products, Inc. LBH Class II 1995-09-08
K953167 ULTRACID DISINFECTING SOLOUTION Ultradent Products, Inc. LBH Class II 1995-09-08
K953331 COMBINATION KIT Steri-Oss, Inc. DZE Class II 1995-09-08

12,679 clearances in the Dental panel. Data: openFDA.