2020-1/2 TO 2220 VARIOUS DENTAL WAX & MODELLING CA
FDA 510(k) clearance K851727 · decided 1985-07-02
Clearance details
- K-number
- K851727
- Device name
- 2020-1/2 TO 2220 VARIOUS DENTAL WAX & MODELLING CA
- Applicant
- Artiberia
- Decision
- Substantially Equivalent
- Date received
- 1985-04-25
- Decision date
- 1985-07-02
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- EIK
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- San Antonio, TX, 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 |
|---|---|---|
| NEOCALEX (K013993) | Stephen M Koral, Dmd | 2002-02-22 |
| PERIO CONTROL II (K972642) | Estrad B.V. | 1998-01-26 |
| PDS-2000 (K902653) | Intl. Equipment and Supply Corp. | 1990-09-13 |
| ROOT CANAL ORGANIZER (K860817) | Pacific Union Dental, Inc. | 1986-03-17 |
Recalls involving this device
No recalls on record reference this clearance.