ULTRACAPS S
FDA 510(k) clearance K081273 · decided 2008-07-10
Clearance details
- K-number
- K081273
- Device name
- ULTRACAPS S
- Applicant
- Sdi , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2008-05-05
- Decision date
- 2008-07-10
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- OIV
- Device class
- 2
- Regulation number
- 872.3070
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Bayswater, Victoria, AU
- 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 |
|---|---|---|
| Arial Dental, Mistral Dental Amalgam, World Work Dental Amalgam, BMS Non Gamma 2 Alloy, Flexi Alloy, Hi-S Alloy, WW Dental Amalgam, Hi - Mix, Non Gamma 2 Alloy (K223182) | Worldwork S.R.L | 2023-05-01 |
| NEW STETIC DENTAL AMALGAM ALLOY (K140125) | New Stetic | 2014-04-29 |
Recalls involving this device
No recalls on record reference this clearance.