NIVEOUS LIQUID DAM
FDA 510(k) clearance K021613 · decided 2002-06-20
Clearance details
- K-number
- K021613
- Device name
- NIVEOUS LIQUID DAM
- Applicant
- Shofu Dental Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-05-16
- Decision date
- 2002-06-20
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- EIE
- Device class
- 1
- Regulation number
- 872.6300
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- San Marcos, CA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| PULPDENT PUTTY DAM (K022522) | Pulpdent Corporation | 2002-09-26 |
| LIGHT CURE DENTAL DAM (K021524) | Prime Dental Manufacturing, Inc. | 2002-07-19 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.