RUBBER DAM
FDA 510(k) clearance K780745 · decided 1978-05-12
Clearance details
- K-number
- K780745
- Device name
- RUBBER DAM
- Applicant
- Hygienic Dental Mfg., Co., The
- Decision
- Substantially Equivalent
- Date received
- 1978-04-13
- Decision date
- 1978-05-12
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- EIE
- Device class
- 1
- Regulation number
- 872.6300
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
Recalls involving this device
No recalls on record reference this clearance.