FDA Product Code
FDA Product Code EBI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3760
510(k) Clearances — 335 records · page 4 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K864709 | IVOCRYL HEAT CURE & IVOCRYL QUICK DENTURE MATERIAL | Ivoclar USA, Inc. | 1987-02-10 | Traditional | PDF ↗ |
| K864757 | MODIFIED VINYLAC PRESS PACK DENTURE RESIN | Astron Dental Corp. | 1987-02-10 | Traditional | PDF ↗ |
| K863324 | TRIAD IMPACT | Dentsply Intl. | 1986-09-05 | Traditional | PDF ↗ |
| K862558 | AUSTENAL ACUPAC HI DENTURE BASE MATERIAL | Austenal Dental, Inc. | 1986-07-18 | Traditional | PDF ↗ |
| K861239 | ACRYLIC SOLDER | Parker Laboratories, Inc. | 1986-04-17 | Traditional | PDF ↗ |
| K853094 | EMPEROR 5/20 & STD, C.C, ORTHO, PSP REFIT, PERISEA | Psp Dental Co., Ltd. | 1986-04-04 | Traditional | PDF ↗ |
| K852741 | DURA CONDITIONER | Reliance Dental Mfg. Co. | 1985-09-23 | Traditional | PDF ↗ |
| K850650 | DENTAL ACRYLIC POLYMERS | Cole Polymers , Ltd. | 1985-05-22 | Traditional | PDF ↗ |
| K842476 | CREDENT RADIOPAQUE CROWN & BRIDE | Credent Co. | 1984-12-03 | Traditional | PDF ↗ |
| K842477 | CREDENT RADIOPAQUE DENTURE RESIN | Credent Co. | 1984-12-03 | Traditional | PDF ↗ |
| K842576 | CLEAR LINER | Harry J. Bosworth Co. | 1984-09-27 | Traditional | PDF ↗ |
| K833270 | ASTRON 77 INJECTION DENTURE RESIN | Astron Dental Corp. | 1984-07-19 | Traditional | PDF ↗ |
| K840405 | BOSWORTH DENT-ALL | Harry J. Bosworth Co. | 1984-05-01 | Traditional | PDF ↗ |
| K840548 | RESIL | Parker Laboratories, Inc. | 1984-04-17 | Traditional | PDF ↗ |
| K834409 | DENTURE BASE RESIN | Dentsply Intl. | 1984-02-27 | Traditional | PDF ↗ |
| K834435 | CROWN & BRIDGE RESIN | Rohm and Haas Co. | 1984-02-21 | Traditional | PDF ↗ |
| K831095 | ROYALE II | Factor, Ii, Inc. | 1983-08-31 | Traditional | PDF ↗ |
| K831647 | DENTURE RELINING, REPAIR/REBASING RESIN | Dentsply Intl. | 1983-06-30 | Traditional | PDF ↗ |
| K831269 | VINYLAC PRESS-PACK DENTURE RESIN | Astron Dental Corp. | 1983-06-08 | Traditional | PDF ↗ |
| K823568 | POLY-TONE DENTURE BASE RESIN | General Dental Products, Inc. | 1983-01-12 | Traditional | PDF ↗ |
| K821217 | REIGNING DENTURE | Oki Shiks USA , Ltd. | 1982-06-07 | Traditional | PDF ↗ |
| K821230 | SOFTIC 49 | The Healthcare Group Laboratories, Inc. | 1982-05-28 | Traditional | PDF ↗ |
| K820673 | SELF-CURING HARD DENTURE LINER | Coe Laboratories, Inc. | 1982-04-09 | Traditional | PDF ↗ |
| K810869 | SILICONE ELASTOMER KIT | Rapid Injection Systems Corp. | 1981-04-29 | Traditional | PDF ↗ |
| K810687 | SR-IVOCAP | J. Aderer, Inc. | 1981-04-14 | Traditional | PDF ↗ |
| K810094 | DENTURE RUBBER BASE MATERIAL | Bosworth Co. | 1981-02-02 | Traditional | PDF ↗ |
| K802490 | REIGNING DENTURE | Oki Shiks USA , Ltd. | 1980-11-19 | Traditional | PDF ↗ |
| K802491 | REIGNING REPAIR EPOXY RESIN | Oki Shiks USA , Ltd. | 1980-11-12 | Traditional | PDF ↗ |
| K801234 | REIGNING DENTURE MADE OF POLYCARB. RESIN | Oki Shiks USA , Ltd. | 1980-06-09 | Traditional | PDF ↗ |
| K800458 | ORTHODONTICARTIDE | European Orthodontic Products | 1980-03-25 | Traditional | PDF ↗ |
| K800400 | MAXUM DENTURE RESIN | Dentsply Intl. | 1980-03-12 | Traditional | PDF ↗ |
| K792427 | PERMA-CRYL 20 | Coe Laboratories, Inc. | 1979-12-13 | Traditional | PDF ↗ |
| K792042 | DENTURE BASE RESIN | Dentsply Intl. | 1979-11-30 | Traditional | PDF ↗ |
| K790325 | REPRODENT | Premier Dental Products Co. | 1979-03-02 | Traditional | PDF ↗ |
| K780786 | DENTURE RELINE MATERIAL | Dentsply Intl. | 1978-06-14 | Traditional | PDF ↗ |
Product code EBI · Class II · Dental. Data: openFDA.