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 |
|---|---|---|---|
| Feb 10, 1987 | K864757 | MODIFIED VINYLAC PRESS PACK DENTURE RESIN Astron Dental Corp. | EBI |
| Feb 10, 1987 | K864709 | IVOCRYL HEAT CURE & IVOCRYL QUICK DENTURE MATERIAL Ivoclar USA, Inc. | EBI |
| Sep 5, 1986 | K863324 | TRIAD IMPACT Dentsply Intl. | EBI |
| Jul 18, 1986 | K862558 | AUSTENAL ACUPAC HI DENTURE BASE MATERIAL Austenal Dental, Inc. | EBI |
| Apr 17, 1986 | K861239 | ACRYLIC SOLDER Parker Laboratories, Inc. | EBI |
| Apr 4, 1986 | K853094 | EMPEROR 5/20 & STD, C.C, ORTHO, PSP REFIT, PERISEA Psp Dental Co., Ltd., GB | EBI |
| Sep 23, 1985 | K852741 | DURA CONDITIONER Reliance Dental Mfg. Co. | EBI |
| May 22, 1985 | K850650 | DENTAL ACRYLIC POLYMERS Cole Polymers , Ltd., GB | EBI |
| Dec 3, 1984 | K842477 | CREDENT RADIOPAQUE DENTURE RESIN Credent Co. | EBI |
| Dec 3, 1984 | K842476 | CREDENT RADIOPAQUE CROWN & BRIDE Credent Co. | EBI |
| Sep 27, 1984 | K842576 | CLEAR LINER Harry J. Bosworth Co. | EBI |
| Jul 19, 1984 | K833270 | ASTRON 77 INJECTION DENTURE RESIN Astron Dental Corp. | EBI |
| May 1, 1984 | K840405 | BOSWORTH DENT-ALL Harry J. Bosworth Co. | EBI |
| Apr 17, 1984 | K840548 | RESIL Parker Laboratories, Inc. | EBI |
| Feb 27, 1984 | K834409 | DENTURE BASE RESIN Dentsply Intl. | EBI |
| Feb 21, 1984 | K834435 | CROWN & BRIDGE RESIN Rohm and Haas Co. | EBI |
| Aug 31, 1983 | K831095 | ROYALE II Factor, Ii, Inc. | EBI |
| Jun 30, 1983 | K831647 | DENTURE RELINING, REPAIR/REBASING RESIN Dentsply Intl. | EBI |
| Jun 8, 1983 | K831269 | VINYLAC PRESS-PACK DENTURE RESIN Astron Dental Corp. | EBI |
| Jan 12, 1983 | K823568 | POLY-TONE DENTURE BASE RESIN General Dental Products, Inc. | EBI |
| Jun 7, 1982 | K821217 | REIGNING DENTURE Oki Shiks USA , Ltd. | EBI |
| May 28, 1982 | K821230 | SOFTIC 49 The Healthcare Group Laboratories, Inc. | EBI |
| Apr 9, 1982 | K820673 | SELF-CURING HARD DENTURE LINER Coe Laboratories, Inc. | EBI |
| Apr 29, 1981 | K810869 | SILICONE ELASTOMER KIT Rapid Injection Systems Corp. | EBI |
| Apr 14, 1981 | K810687 | SR-IVOCAP J. Aderer, Inc. | EBI |
| Feb 2, 1981 | K810094 | DENTURE RUBBER BASE MATERIAL Bosworth Co. | EBI |
| Nov 19, 1980 | K802490 | REIGNING DENTURE Oki Shiks USA , Ltd. | EBI |
| Nov 12, 1980 | K802491 | REIGNING REPAIR EPOXY RESIN Oki Shiks USA , Ltd. | EBI |
| Jun 9, 1980 | K801234 | REIGNING DENTURE MADE OF POLYCARB. RESIN Oki Shiks USA , Ltd. | EBI |
| Mar 25, 1980 | K800458 | ORTHODONTICARTIDE European Orthodontic Products | EBI |
| Mar 12, 1980 | K800400 | MAXUM DENTURE RESIN Dentsply Intl. | EBI |
| Dec 13, 1979 | K792427 | PERMA-CRYL 20 Coe Laboratories, Inc. | EBI |
| Nov 30, 1979 | K792042 | DENTURE BASE RESIN Dentsply Intl. | EBI |
| Mar 2, 1979 | K790325 | REPRODENT Premier Dental Products Co. | EBI |
| Jun 14, 1978 | K780786 | DENTURE RELINE MATERIAL Dentsply Intl. | EBI |
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