Resin, Denture, Relining, Repairing, Rebasing
Regulation 872.3760
10510(k)s in 12 months (335 all time)
0recalls in 12 months (16 all time)
10recalls that name a 510(k)
Top companies in EBI
| Company | 510(k)s | Recalls |
|---|---|---|
| Dentsply Intl. | 16 | 0 |
| Heraeus Kulzer, Inc. | 13 | 0 |
| GC America, Inc. | 12 | 0 |
| Cmp Industries, LLC | 5 | 6 |
| Harry J. Bosworth Co. | 8 | 0 |
| Lang Dental Mfg. Co., Inc. | 7 | 1 |
| Voco GmbH | 8 | 0 |
| Vertex-Dental B.V. | 7 | 0 |
| Dentsply Sirona | 6 | 0 |
| Stick Tech , Ltd. | 6 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 31, 1993 | K926406 | DUAL CURE RELINE MATERIAL Dentsply Intl. | EBI |
| Mar 31, 1993 | K925062 | PERMAFLEX PERMANENT SOFT DENTURE RELINER Protech Professional Products, Inc. | EBI |
| Jan 11, 1993 | K925275 | SOFT DENTURE RELINE MATERIAL ELASTOLINE Great Lakes Orthodontics, Ltd. | EBI |
| Nov 4, 1992 | K924422 | PALABOND Heraeus Kulzer, Inc. | EBI |
| Sep 16, 1992 | K915898 | PALADUR Heraeus Kulzer, Inc. | EBI |
| Mar 25, 1992 | K912990 | CONVERBASE Wilde-USA, Inc. | EBI |
| Mar 20, 1992 | K920557 | WIL-O-DONT ORTHODONTIC MATERIAL/WIL-O-LUX Wilde-USA, Inc. | EBI |
| Feb 3, 1992 | K912993 | WILDE DENTURE RESINS Wilde-USA, Inc. | EBI |
| Jan 31, 1992 | K915377 | SR-IVOCAP PLUS Ivoclar North America, Inc. | EBI |
| Dec 19, 1991 | K912991 | WILDE AUXILIARIES Wilde-USA, Inc. | EBI |
| Oct 17, 1991 | K913655 | PROBASE HOT AND PROBASE COLD Ivoclar North America, Inc. | EBI |
| Oct 9, 1991 | K913699 | MODERN MATERIALS ORTHODONTIC RESIN Heraeus Kulzer, Inc. | EBI |
| Oct 9, 1991 | K913698 | ACCELAR 20 ADVANCE RAPID CURE REPAIR MATERIAL Heraeus Kulzer, Inc. | EBI |
| Oct 7, 1991 | K913040 | RIBBOND(TM) Ribbond, Inc. | EBI |
| Jul 11, 1991 | K910795 | COMFOR-DENT DENTURE LINER Comfort Acrylics Co. | EBI |
| Jun 6, 1991 | K910465 | MELIODENT, DENTURE RESIN Heraeus Kulzer, Inc. | EBI |
| Apr 29, 1991 | K905702 | NEW TRIAD TRANSHEET DENTURE BASE MATERIAL Dentsply Intl. | EBI |
| Oct 4, 1990 | K902972 | FLEXOR (DENTURE ACRYLIC RELINE MATERIAL) Cmp Industries, LLC | EBI |
| Jul 27, 1990 | K902115 | PALAPRESS(R) VARIO RESIN Kulzer, Inc. | EBI |
| Jun 26, 1990 | K901621 | NEW PER-FIT(R) IMPROVED Dental Product Co. | EBI |
| Jun 22, 1990 | K901789 | PALADON(R) 65 Kulzer, Inc. | EBI |
| May 15, 1990 | K900799 | COMFORT ACRYLICS PLIABLE DENTURE LINERS & SPLINTS Comfort Acrylics Co. | EBI |
| May 15, 1990 | K900301 | NOVUS BONDING AGENT The Hygenic Corp. | EBI |
| May 15, 1990 | K896981 | TOKUSO REBASE Tokuyama America, Inc. | EBI |
| May 15, 1990 | K896980 | PALFIQUE LIGHT LINER Tokuyama America, Inc. | EBI |
| Apr 16, 1990 | K896139 | SR-IVOSEAL Ivoclar North America, Inc. | EBI |
| Apr 16, 1990 | K896130 | SR-IVOCAP Ivoclar North America, Inc. | EBI |
| Feb 22, 1990 | K896719 | PRIMER-P ADHESIVE AGENT Parkell | EBI |
| Dec 21, 1989 | K895714 | ORTHO-KEV APPLIANCE REINFORCING SYSTEM American Orthodontics | EBI |
| Dec 18, 1989 | K895742 | LITELINE VLC SOFT RELINE Dentsply Intl. | EBI |
| Oct 24, 1989 | K895222 | CURAY-FORM Scientific Pharmaceuticals, Inc. | EBI |
| Oct 17, 1989 | K894564 | RELIANCE LIGHT CURE RETAINER ACRYLIC Reliance Orthodontic Products, Inc. | EBI |
| Jun 16, 1989 | K892452 | PALASEAL(R) Kulzer, Inc. | EBI |
| May 1, 1989 | K890830 | DENTURE RESIN G-C Intl. Corp. | EBI |
| Jan 30, 1989 | K884865 | PERMASEAL AND DENTURE SEAL American Mfg., Inc. | EBI |
| Jan 27, 1989 | K884751 | DANSU PERMANENT CHAIR SOFT LINER American Mfg., Inc. | EBI |
| Oct 20, 1988 | K883799 | BASE, DENTURE, RELINING, REPAIRING, REBASING,RESIN Austenal Dental, Inc. | EBI |
| Aug 12, 1988 | K882482 | TRIAD ORTHODONTIC GEL Dentsply Intl. | EBI |
| Jul 21, 1988 | K881245 | DENT-URE LINER SOFT RESILIENT DENTURE LINING MATER Cadco Dental Products, Inc. | EBI |
| Dec 23, 1987 | K874025 | 2ND MODIFIED VINYLAC PRESS PACK DENTURE RESIN Astron Dental Corp. | EBI |
| Nov 20, 1987 | K873738 | ACRYLIC BASE DENTURE MATERIALS E&D Dental Manufacturing Co. | EBI |
| Aug 10, 1987 | K871849 | LIGHT CURE DENTURE GLAZE Austenal Dental, Inc. | EBI |
| Jun 17, 1987 | K871497 | LINER OR GSRI-PNF Gulf South Research Institute | EBI |
| May 19, 1987 | K871038 | LUTEMOLL (BIOPLAST) B. L. Dental Co. | EBI |
| Apr 15, 1987 | K871312 | FIBREFLEX Biomedical Composites, Ltd. | EBI |
| Mar 19, 1987 | K870908 | STEADY RESIN Great Lakes Orthodontics, Ltd. | EBI |
| Mar 11, 1987 | K863630 | AUSTENAL ACUPAC 20 DENTURE BASE MATERIAL Austenal Dental, Inc. | EBI |
| Feb 25, 1987 | K864708 | SR 3/60 NF DENTURE MATER. & SELF-CURE DENT. RESIN Ivoclar USA, Inc. | EBI |
| Feb 19, 1987 | K870148 | DURA ORTHO ACRYLIC Reliance Dental Mfg. Co. | EBI |
| Feb 19, 1987 | K862557 | AUSTENAL ACUSOFT SOFT LINER Austenal Dental, Inc. | EBI |
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