Sealant, Pit And Fissure, And Conditioner
Regulation 872.3765
1510(k)s in 12 months (131 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in EBC
| Company | 510(k)s | Recalls |
|---|---|---|
| Dentsply Intl. | 11 | 0 |
| Pulpdent Corp. | 10 | 0 |
| Ultradent Products, Inc. | 7 | 1 |
| Voco GmbH | 5 | 0 |
| Confi-Dental Products Co. | 4 | 0 |
| 3M Company | 3 | 0 |
| Bisco, Inc. | 3 | 0 |
| Foremost Dental Mfg., Inc. | 3 | 0 |
| Harry J. Bosworth Co. | 3 | 0 |
| Johnson & Johnson Professionals, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 22, 1999 | K992518 | PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM Dentsply Intl. | EBC |
| Aug 27, 1999 | K992516 | DYRACT SEAL COMPOMER PIT & FISSURE SEALANT Dentsply Intl. | EBC |
| Aug 20, 1999 | K991909 | DELTON FS WITH FLUORIDE PIT & FISSURE SEALANT Dentsply Intl. | EBC |
| Jul 26, 1999 | K991902 | LC PIT & FISSURE SEALANT Bosworth Co. | EBC |
| Jun 10, 1999 | K991099 | AMERICAN DENTAL PRODUCTS ETCH-DETECT American Dental Products, Inc. | EBC |
| May 14, 1999 | K990650 | CONSEAL F Southern Dental Industries, Inc. | EBC |
| Mar 3, 1999 | K990306 | HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025 Kay See Dental Mfg. Co. | EBC |
| Oct 6, 1998 | K982564 | DELTON FS DIRECT DELIVERY SYSTEM Dentsply Intl. | EBC |
| Nov 25, 1997 | K973541 | MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED Medental Intl. | EBC |
| Mar 27, 1997 | K965091 | TEETHMATE F-1 Kuraray Company, Ltd. | EBC |
| Nov 12, 1996 | K963921 | PULPDENT SEAL-RITE UDMA Pulpdent Corp. | EBC |
| Apr 23, 1996 | K961190 | GLY-ETCH Centrix, Inc. | EBC |
| Mar 8, 1996 | K954867 | IONOSIT SEAL Foremost Dental Mfg., Inc. | EBC |
| Jan 4, 1996 | K954827 | SEALITE FL Sybron Dental Specialties, Inc. | EBC |
| Oct 30, 1995 | K954701 | AMERICAN DENTAL PRODUCTS PIT & FISSUE SEALANT LIGHT CURING American Dental Products, Inc. | EBC |
| Aug 18, 1995 | K952240 | TOOTH PREPARATION CONDITIONER, PRE-IMPRESSION Jeneric/Pentron, Inc. | EBC |
| May 3, 1995 | K951296 | DELTON F PIT & FISSURE SEALANT Dentsply Intl. | EBC |
| Jan 17, 1995 | K945378 | PULPDENT CHEMICAL CURE PIT AND FISSURE SEALANT Pulpdent Corp. | EBC |
| Jan 21, 1994 | K935727 | P&FS PIT AND FISSURE SEALANT Jedental Co., Inc. | EBC |
| Sep 20, 1993 | K932794 | PULPDENT SEAL-RITE LOW VISCOSITY Pulpdent Corp. | EBC |
| Sep 15, 1993 | K932078 | HELIOSEAL F Ivoclar North America, Inc. | EBC |
| Jul 22, 1993 | K932002 | BARITONE C2, MODIFICATION Confi-Dental Products Co. | EBC |
| Jul 22, 1993 | K931869 | ULTRASEAL XT PIT AND FISSURE SEALANT PRODUCT LINE Ultradent Products, Inc. | EBC |
| Jul 22, 1993 | K931868 | PRIMADRY PRODUCT LINE Ultradent Products, Inc. | EBC |
| Jul 22, 1993 | K931857 | SUPPLEMENTAL FORMULA TO BARITONE L3 SEALANT Confi-Dental Products Co. | EBC |
| Mar 16, 1993 | K924824 | MICRODOSE PIT AND FISSURE SEALANT-CLEAR OR WHITE Unicep | EBC |
| Dec 23, 1992 | K923895 | QUIKSEAL Mirage Dental Systems | EBC |
| Oct 16, 1992 | K924635 | ALPHA-DENT PIT AND FISSURE SEALANT Wallace A. Erickson & Co. | EBC |
| Sep 28, 1992 | K921600 | ULTRADENT PROD LI CURED PIT/FISSURE SEAL PROD LINE Ultradent Products, Inc. | EBC |
| Sep 28, 1992 | K921599 | ULTRADENT PRODUCT DENTIN CONDITION & SEAL PROD LIN Ultradent Products, Inc. | EBC |
| Aug 27, 1992 | K913853 | FISSURE SEALER Ortho Source | EBC |
| Jan 17, 1992 | K915095 | ESTISEAL LC Heraeus Kulzer, Inc. | EBC |
| Oct 23, 1991 | K914322 | BARITONE C2 & BARITONE L3 Confi-Dental Products Co. | EBC |
| Oct 23, 1991 | K914319 | PIT AND FISSURE SEALANT PRODUCTS Confi-Dental Products Co. | EBC |
| Jun 10, 1991 | K911287 | PULPDENT SEAL RITE Pulpdent Corp. | EBC |
| May 7, 1991 | K910813 | MET-ETCH Gresco Products, Inc. | EBC |
| Apr 29, 1991 | K905582 | POTASSIUM NITRATE COMPOSITE RESTORATION PIT AND Milton Hodosh, M.D. | EBC |
| Sep 12, 1990 | K902742 | DEGUFILL (TM) WHIT-SEALANT Degussa AG | EBC |
| Jul 20, 1990 | K902022 | SEAL RITE(TM) Pulpdent Corp. | EBC |
| Jul 13, 1990 | K902023 | SEAL RITE PROCEDURE KIT(TM) Pulpdent Corp. | EBC |
| Apr 23, 1990 | K896341 | FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT & FISSURE Dentsply Intl. | EBC |
| Mar 14, 1990 | K897027 | TEETHMATE-A Kuraray Co. | EBC |
| May 1, 1989 | K891140 | OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT Coe Laboratories, Inc. | EBC |
| Mar 29, 1989 | K890494 | FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFS Macrochem Corp. | EBC |
| Feb 13, 1989 | K890464 | ZENITH 40% PHOSPHORIC ACID GEL Foremost Dental Mfg., Inc. | EBC |
| Feb 29, 1988 | K875091 | ORALIN TLC LIGHT CURED PIT AND FISSURE SEALANT Mission White Dental, Inc. | EBC |
| Feb 8, 1988 | K874944 | MODIFIED PRISMA SHIELD PIT & FISSURE SEALANT Dentsply Intl. | EBC |
| Jan 28, 1988 | K874557 | BISCO PORCELAIN REPAIR KIT Bisco, Inc. | EBC |
| Jan 28, 1988 | K874556 | BISCO PIT AND FISSURE SEALANT Bisco, Inc. | EBC |
| Sep 15, 1987 | K873069 | MODIFIED VISIO-SEAL Espe GmbH (Us) | EBC |
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