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
FDA 510(k) clearance K223182 · decided 2023-05-01
Clearance details
- K-number
- K223182
- Device name
- 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
- Applicant
- Worldwork S.R.L
- Decision
- Substantially Equivalent
- Date received
- 2022-10-11
- Decision date
- 2023-05-01
- Days to decision
- 202 days
- Clearance type
- Abbreviated
- Product code
- OIV
- Device class
- 2
- Regulation number
- 872.3070
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Montebello, IT
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Worldwork S.R.L
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| NEW STETIC DENTAL AMALGAM ALLOY (K140125) | New Stetic | 2014-04-29 |
| ULTRACAPS S (K081273) | Sdi , Ltd. | 2008-07-10 |
Recalls involving this device
No recalls on record reference this clearance.