EIE
33 FDA 510(k) clearances · Product code
87 daysmedian time to decision
218 days90th percentile
33clearances measured
FDA profile
- Official device name
- Dam, Rubber
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.6300
- Medical specialty
- Dental
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1996: 2 · 1997: 3 · 1998: 1 · 1999: 1 · 2003: 2 · 2004: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| armor LC (K182118) | Mavrik Dental Systems, Ltd. | 2019-05-03 |
| Triumph Resin Dam (K151945) | Denali Corporation | 2016-02-18 |
| BARI-KAD PACKING DEVICE (K050318) | Bioenvelop Agro, Inc. | 2005-03-04 |
| GC TION GINGIVAL PROTECTOR (K043301) | GC America, Inc. | 2005-01-25 |
| BRITESMILE MASKING CREAM (K040797) | Britesmile, Inc. | 2004-04-02 |
| PULPDENT PUTTY DAM (K022522) | Pulpdent Corporation | 2002-09-26 |
| LIGHT CURE DENTAL DAM (K021524) | Prime Dental Manufacturing, Inc. | 2002-07-19 |
| NIVEOUS LIQUID DAM (K021613) | Shofu Dental Corp. | 2002-06-20 |
| BRITESMILE BARRIER MATERIAL (K010935) | Britesmile, Inc. | 2001-09-05 |
| POWER BLOCK (K983227) | Kreativ, Inc. | 1998-12-11 |
| FASTDAM (K972775) | Interdent, Inc. | 1998-02-27 |
| DENTAL DAM SILICONE (K961472) | Worldwide Dental, Inc. | 1996-08-07 |
| DENTAL DAM (K954990) | The Hygenic Corp. | 1996-01-26 |
| ROYAL SHIELD NON-STERILE POWDER-FREE RUBBER DAMS (K952628) | Elastomade Accessories Sdn Bhd | 1995-10-19 |
| ROYAL SHIELD RUBBER DAMS (K942992) | Elastomade Accessories Sdn Bhd | 1994-09-21 |
| DENTAL RUBBER DAM (K923157) | Aseptico, Inc. | 1993-07-22 |
| RUBBER DAM CLAMP (K923163) | Aseptico, Inc. | 1992-12-28 |
| MINIDAM II (K921771) | Delsan Dental Systems | 1992-09-17 |
| STANDARD RUBBER DAM WITH OR WITHOUT FRAMES (K905470) | Elastomade Accessories Sdn Bhd | 1991-04-25 |
| RUBBER, DENTAL DAM (NON-STERILE) (K901236) | Naturub Sdn. Bhd. | 1990-06-06 |
| WEDJETS (K900844) | The Hygenic Corp. | 1990-04-16 |
| MADEGOM LTDA. DENTAL DAM (K894120) | Madegom | 1989-08-21 |
| KITCHIN DENTAL ABCESS DRAIN (K885231) | Kitchin, Inc. | 1989-05-16 |
| RUBBER DAM (K890667) | Cost Rite Health Products, Inc. | 1989-03-29 |
| HANDIDAM (K884828) | Aseptico, Inc. | 1989-02-03 |
| DREAM DAM (K875255) | Dental Dam, Inc. | 1988-03-18 |
| DREAM DAM (K864096) | Dental Dam, Inc. | 1986-11-18 |
| IVORY PREMIUM RUBBER DAM (K863816) | Columbus Dental Mfg. Co. | 1986-10-27 |
| DEN-MAT PAINT-ON RUBBER DAM (K852630) | Den-Mat Corp. | 1985-12-18 |
| DENT-DR. VACU-FRAME (K851045) | Dent-Dr. | 1985-04-22 |
| DENTI-D RUBBER DAM (K842844) | Fema Corp. | 1984-08-17 |
| DENTAL RUBBERDAM (K833610) | Center For Marketing Services | 1984-01-10 |
| RUBBER DAM (K780745) | Hygienic Dental Mfg., Co., The | 1978-05-12 |
Track EIE automatically
Every clearance here is in the API, with alerts when new ones post.