FDA Product Code
FDA Product Code EIE — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.6300
510(k) Clearances — 33 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K182118 | armor LC | Mavrik Dental Systems, Ltd. | 2019-05-03 | Traditional | PDF ↗ |
| K151945 | Triumph Resin Dam | Denali Corporation | 2016-02-18 | Traditional | PDF ↗ |
| K050318 | BARI-KAD PACKING DEVICE | Bioenvelop Agro, Inc. | 2005-03-04 | Traditional | PDF ↗ |
| K043301 | GC TION GINGIVAL PROTECTOR | GC America, Inc. | 2005-01-25 | Traditional | PDF ↗ |
| K040797 | BRITESMILE MASKING CREAM | Britesmile, Inc. | 2004-04-02 | Special | PDF ↗ |
| K022522 | PULPDENT PUTTY DAM | Pulpdent Corporation | 2002-09-26 | Traditional | PDF ↗ |
| K021524 | LIGHT CURE DENTAL DAM | Prime Dental Manufacturing, Inc. | 2002-07-19 | Traditional | PDF ↗ |
| K021613 | NIVEOUS LIQUID DAM | Shofu Dental Corp. | 2002-06-20 | Traditional | PDF ↗ |
| K010935 | BRITESMILE BARRIER MATERIAL | Britesmile, Inc. | 2001-09-05 | Traditional | PDF ↗ |
| K983227 | POWER BLOCK | Kreativ, Inc. | 1998-12-11 | Traditional | PDF ↗ |
| K972775 | FASTDAM | Interdent, Inc. | 1998-02-27 | Traditional | PDF ↗ |
| K961472 | DENTAL DAM SILICONE | Worldwide Dental, Inc. | 1996-08-07 | Traditional | PDF ↗ |
| K954990 | DENTAL DAM | The Hygenic Corp. | 1996-01-26 | Traditional | PDF ↗ |
| K952628 | ROYAL SHIELD NON-STERILE POWDER-FREE RUBBER DAMS | Elastomade Accessories Sdn Bhd | 1995-10-19 | Traditional | PDF ↗ |
| K942992 | ROYAL SHIELD RUBBER DAMS | Elastomade Accessories Sdn Bhd | 1994-09-21 | Traditional | PDF ↗ |
| K923157 | DENTAL RUBBER DAM | Aseptico, Inc. | 1993-07-22 | Traditional | PDF ↗ |
| K923163 | RUBBER DAM CLAMP | Aseptico, Inc. | 1992-12-28 | Traditional | PDF ↗ |
| K921771 | MINIDAM II | Delsan Dental Systems | 1992-09-17 | Traditional | PDF ↗ |
| K905470 | STANDARD RUBBER DAM WITH OR WITHOUT FRAMES | Elastomade Accessories Sdn Bhd | 1991-04-25 | Traditional | PDF ↗ |
| K901236 | RUBBER, DENTAL DAM (NON-STERILE) | Naturub Sdn. Bhd. | 1990-06-06 | Traditional | PDF ↗ |
| K900844 | WEDJETS | The Hygenic Corp. | 1990-04-16 | Traditional | PDF ↗ |
| K894120 | MADEGOM LTDA. DENTAL DAM | Madegom | 1989-08-21 | Traditional | PDF ↗ |
| K885231 | KITCHIN DENTAL ABCESS DRAIN | Kitchin, Inc. | 1989-05-16 | Traditional | PDF ↗ |
| K890667 | RUBBER DAM | Cost Rite Health Products, Inc. | 1989-03-29 | Traditional | PDF ↗ |
| K884828 | HANDIDAM | Aseptico, Inc. | 1989-02-03 | Traditional | PDF ↗ |
| K875255 | DREAM DAM | Dental Dam, Inc. | 1988-03-18 | Traditional | PDF ↗ |
| K864096 | DREAM DAM | Dental Dam, Inc. | 1986-11-18 | Traditional | PDF ↗ |
| K863816 | IVORY PREMIUM RUBBER DAM | Columbus Dental Mfg. Co. | 1986-10-27 | Traditional | PDF ↗ |
| K852630 | DEN-MAT PAINT-ON RUBBER DAM | Den-Mat Corp. | 1985-12-18 | Traditional | PDF ↗ |
| K851045 | DENT-DR. VACU-FRAME | Dent-Dr. | 1985-04-22 | Traditional | PDF ↗ |
| K842844 | DENTI-D RUBBER DAM | Fema Corp. | 1984-08-17 | Traditional | PDF ↗ |
| K833610 | DENTAL RUBBERDAM | Center For Marketing Services | 1984-01-10 | Traditional | PDF ↗ |
| K780745 | RUBBER DAM | Hygienic Dental Mfg., Co., The | 1978-05-12 | Traditional | PDF ↗ |
Product code EIE · Class I · Dental. Data: openFDA.