Dentsply Intl.
Dentsply Intl. holds FDA 510(k) medical device clearances, first cleared 1976, most recent 2013.
Top product codes for Dentsply Intl.
Recent clearances by Dentsply Intl.
1–100 of 279- K123615 — IRIS - HIGH STRENGTH GLASS CERAMIC
- K072730 — FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS
- K070538 — XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE
- K070019 — CARRARA VOLUMIA
- K061427 — PRE-IMPRESSION CONDITIONING SOLUTION
- K052334 — CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131
- K051707 — ECLIPSE BONDING AGENT
- K051463 — XENO ADHESIVE WITH ACTIVATOR
- K051462 — MODIFICATION TO: CERCON BASE
- K050880 — DYRACT EXTRA RESTORATIVE
- K050750 — LC BRACKET ADHESIVE SYSTEM
- K043247 — DUCERA ALLCERAM
- K042905 — NEO-CLIP ORTHODONTIC BRACKET ACCESSORY
- K041272 — DYRACT CEM PLUS CEMENT
- K042178 — ORTHODONTIC CERAMIC BRACKETS
- K041707 — CERCON CERAM EXPRESS CERAMIC SYSTEM
- K040906 — CALIBRA CEMENT
- K041141 — DENTSPLY CAVITRON JET WAVE AIR POLISHING PROPHYLAXIS SYSTEM, MODEL G125
- K040895 — INTEGRITY TEMPORARY CEMENT
- K040375 — IDEAL 1 ORTHODONTIC BAND CEMENT
- K040635 — CARRARA INTERACTION CERAMIC SYSTEM
- K040420 — DUCERAM PLUS CERAMIC SYSTEM
- K040421 — DUCERAGOLD PORCELAINS
- K033703 — IDEAL 1 ORTHODONTIC BRACKET ADHESIVE
- K033667 — CARRARA PRESS SYSTEM
- K032361 — ENDOPURE ROOT CANAL CLEANSER
- K033553 — PFZ PORCELAIN SYSTEM
- K032904 — ACUCAM CONCEPT IV FWT, MODEL 110-0185G1
- K024133 — CLS-2000 UNIT
- K032316 — ORION E ALLOY
- K032317 — ORION GX ALLOY
- K032892 — MODIFICATION TO TRUBYTE DENTURE BASE RESIN SYSTEM
- K031932 — FLUORIDE VARNISH
- K031461 — CARRIER TIPS
- K031145 — ESTYLUS ELECTRIC MOTOR SYSTEM
- K023776 — XENO III DENTAL ADHESIVE
- K022796 — CERCON CERAM S PORCELAIN
- K021805 — SEAL & PROTECT PROTECTIVE SEALANT
- K021416 — AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL
- K021413 — AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL
- K021410 — AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL
- K014188 — NEW PROPHY POWDER
- K012720 — TULSA CONTRA ANGLES
- K011560 — TRUBYTE DENTURE BASE RESIN SYSTEM
- K003921 — DYRACT CEM LCI COMPOMER
- K003518 — RAPIDD HIGHSPEED DENTAL HANDPIECE
- K002387 — COMFORT CONTROL SYRINGE SYSTEM
- K000996 — TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND
- K000112 — ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401
- K000169 — NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN
- K994285 — ORTHORALIX 9200, ORTHORALIX 9200 PLUS, ORTHORALIX 9200 CEPH, ORTHORALIX 9200 PLUS CEPH
- K994211 — ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285
- K992822 — SEAL & PROTECT PROTECTIVE SEALANT FOR EXPOSED DENTINE
- K992519 — NRC NON-RINSE CONDITIONER
- K992956 — LUCITONE FRS FLEXIBEL DENTAL RESIN
- K992518 — PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM
- K992610 — GENDEX 765DC, MODEL 110-0154
- K992516 — DYRACT SEAL COMPOMER PIT & FISSURE SEALANT
- K991909 — DELTON FS WITH FLUORIDE PIT & FISSURE SEALANT
- K983966 — NUPRO PROPHYLAXIS PASTE WITH FLOURIDE AND TRICLOSAN
- K984387 — R-30 AESTHETIC RESTORATIVE
- K982564 — DELTON FS DIRECT DELIVERY SYSTEM
- K982394 — PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM
- K982318 — SPECTRUM 800 CURING UNIT
- K982395 — DYTRACT FLOW RESTORATIVE
- K981620 — MTA MATERIAL II
- K982007 — TRUBYTE DENTURE BOND DENTURE BONDING AGENT
- K981965 — FLOWABLE COMPOSITE
- K980543 — DENOPTIX BARRIER ENVELOPE (SIZE 0-4)
- K980332 — MTA MATERIAL
- K973221 — COMPOSITE 168 RESTORATIVE SYSTEM
- K973235 — DYRACT AP RESTORATIVE
- K974140 — ADHESIVE HYBRID IONOMER CEMENT
- K974035 — CENTURY ALLOY
- K973781 — AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL
- K973782 — AQUASIL XLV SMART WETTING IMPRESSION MATERIAL
- K972573 — LIQCRYLIC PRO DENTAL RESIN
- K971869 — FINESSE ALL-CERAMIC SYSTEM
- K972234 — RCT GEL ROOT CANAL THERAPY GEL
- K971603 — STERILE SUREFLEX FILES AND INSTRUMENTS
- K971606 — STERILE FLEXOFILE FILES AND INSTRUMENTS
- K970123 — DENTSPLY CAVITRON SPS SCALER SYSTEM
- K970342 — CAVITRON JET WITH SPS SYSTEM
- K970433 — AQUASIL RIGID SMART WETTING IMPRESSION MATERIAL
- K964046 — DENTSPLY PRECISION TORQUE SYSTEM
- K964525 — PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BONDING AGENT W/ACTIVATOR
- K964659 — ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM
- K964040 — TRUBYTE SOFT RELINE SYSTEM
- K952614 — JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL
- K962348 — PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT
- K961291 — FINESSE LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS
- K960548 — AH PLUS ROOT CANAL SEALER
- K960823 — PRIME & BOND 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT
- K960028 — ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEM
- K954761 — FINESSE LOW-FUSING PORCELAIN SYSTEM
- K952351 — PRECISE DENTURE BASE RESIN
- K951607 — SUREFLEX FILES
- K951864 — PRIME & BOND DIRECT COMPOSITE BONDING AGENT
- K951425 — SPECTRUM CURING LIGHT POLYMERIZATION UNIT
- K951296 — DELTON F PIT & FISSURE SEALANT
Data sourced from openFDA. This site is unofficial and independent of the FDA.