Product code EIE
- Device name
- Dam, Rubber
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.6300
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K182118 | armor LC | Mavrik Dental Systems, Ltd. | 2019-05-03 |
| K151945 | Triumph Resin Dam | Denali Corporation | 2016-02-18 |
| K050318 | BARI-KAD PACKING DEVICE | Bioenvelop Agro, Inc. | 2005-03-04 |
| K043301 | GC TION GINGIVAL PROTECTOR | GC America, Inc. | 2005-01-25 |
| K040797 | BRITESMILE MASKING CREAM | Britesmile, Inc. | 2004-04-02 |
| K022522 | PULPDENT PUTTY DAM | Pulpdent Corporation | 2002-09-26 |
| K021524 | LIGHT CURE DENTAL DAM | Prime Dental Manufacturing, Inc. | 2002-07-19 |
| K021613 | NIVEOUS LIQUID DAM | Shofu Dental Corp. | 2002-06-20 |
| K010935 | BRITESMILE BARRIER MATERIAL | Britesmile, Inc. | 2001-09-05 |
| K983227 | POWER BLOCK | Kreativ, Inc. | 1998-12-11 |
| K972775 | FASTDAM | Interdent, Inc. | 1998-02-27 |
| K961472 | DENTAL DAM SILICONE | Worldwide Dental, Inc. | 1996-08-07 |
| K954990 | DENTAL DAM | The Hygenic Corp. | 1996-01-26 |
| K952628 | ROYAL SHIELD NON-STERILE POWDER-FREE RUBBER DAMS | Elastomade Accessories Sdn Bhd | 1995-10-19 |
| K942992 | ROYAL SHIELD RUBBER DAMS | Elastomade Accessories Sdn Bhd | 1994-09-21 |
| K923157 | DENTAL RUBBER DAM | Aseptico, Inc. | 1993-07-22 |
| K923163 | RUBBER DAM CLAMP | Aseptico, Inc. | 1992-12-28 |
| K921771 | MINIDAM II | Delsan Dental Systems | 1992-09-17 |
| K905470 | STANDARD RUBBER DAM WITH OR WITHOUT FRAMES | Elastomade Accessories Sdn Bhd | 1991-04-25 |
| K901236 | RUBBER, DENTAL DAM (NON-STERILE) | Naturub Sdn. Bhd. | 1990-06-06 |
| K900844 | WEDJETS | The Hygenic Corp. | 1990-04-16 |
| K894120 | MADEGOM LTDA. DENTAL DAM | Madegom | 1989-08-21 |
| K885231 | KITCHIN DENTAL ABCESS DRAIN | Kitchin, Inc. | 1989-05-16 |
| K890667 | RUBBER DAM | Cost Rite Health Products, Inc. | 1989-03-29 |
| K884828 | HANDIDAM | Aseptico, Inc. | 1989-02-03 |
| K875255 | DREAM DAM | Dental Dam, Inc. | 1988-03-18 |
| K864096 | DREAM DAM | Dental Dam, Inc. | 1986-11-18 |
| K863816 | IVORY PREMIUM RUBBER DAM | Columbus Dental Mfg. Co. | 1986-10-27 |
| K852630 | DEN-MAT PAINT-ON RUBBER DAM | Den-Mat Corp. | 1985-12-18 |
| K851045 | DENT-DR. VACU-FRAME | Dent-Dr. | 1985-04-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07630392900171 | Hysolate | Dent4You AG | 2022-08-22 |
| 07630392900317 | Hysolate | Dent4You AG | 2022-08-22 |
| 07630392900300 | Hysolate | Dent4You AG | 2022-08-22 |
| 07630392900294 | Hysolate | Dent4You AG | 2022-08-22 |
| 07630392900287 | Hysolate | Dent4You AG | 2022-08-22 |
| 07630392900270 | Hysolate | Dent4You AG | 2022-08-22 |
| 07630392900263 | Hysolate | Dent4You AG | 2022-08-22 |
| 07630392900256 | Hysolate | Dent4You AG | 2022-08-22 |
| 07630392900249 | Hysolate | Dent4You AG | 2022-08-22 |
| 07630392900232 | Hysolate | Dent4You AG | 2022-08-22 |
| 07630392900225 | Hysolate | Dent4You AG | 2022-08-22 |
| 07630392900218 | Hysolate | Dent4You AG | 2022-08-22 |
| 07630392900201 | Hysolate | Dent4You AG | 2022-08-22 |
| 07630392900195 | Hysolate | Dent4You AG | 2022-08-22 |
| 07630392900188 | Hysolate | Dent4You AG | 2022-08-22 |
| 07630392900010 | Hysolate | Dent4You AG | 2022-08-22 |
| 07630392900164 | Hysolate | Dent4You AG | 2022-08-22 |
| 07630392900157 | Hysolate | Dent4You AG | 2022-08-22 |
| 07630392900140 | Hysolate | Dent4You AG | 2022-08-22 |
| 07630392900133 | Hysolate | Dent4You AG | 2022-08-22 |
| 07630392900126 | Hysolate | Dent4You AG | 2022-08-22 |
| 07630392900119 | Hysolate | Dent4You AG | 2022-08-22 |
| 07630392900102 | Hysolate | Dent4You AG | 2022-08-22 |
| 07630392900096 | Hysolate | Dent4You AG | 2022-08-22 |
| 07630392900089 | Hysolate | Dent4You AG | 2022-08-22 |
| 07630392900072 | Hysolate | Dent4You AG | 2022-08-22 |
| 07630392900065 | Hysolate | Dent4You AG | 2022-08-22 |
| 07630392900058 | Hysolate | Dent4You AG | 2022-08-22 |
| 07630392900041 | Hysolate | Dent4You AG | 2022-08-22 |
| 07630392900034 | Hysolate | Dent4You AG | 2022-08-22 |