NOVEL DISPENSER/PACKAGE
FDA 510(k) clearance K833955 · decided 1984-01-03
Clearance details
- K-number
- K833955
- Device name
- NOVEL DISPENSER/PACKAGE
- Applicant
- Dentsply Intl.
- Decision
- Substantially Equivalent
- Date received
- 1983-11-16
- Decision date
- 1984-01-03
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- EIY
- Device class
- 1
- Regulation number
- 872.4565
- 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 |
|---|---|---|
| COMPOSITE RESTORATIVE CARRIER (K871909) | Dentsply Intl. | 1987-05-27 |
| 1760/1 TO 2010/34 VARIOUS DENTAL FILLING INSTRUMEN (K851726) | Artiberia | 1985-07-02 |
| MICROFIL CONTOURING INSTRUMENTS (K830776) | Almore Intl., Inc. | 1983-04-28 |
| DENTAL INSTRUMENTS - PLASTIC INSTRUMENTS (K823323) | Miltex, Inc. | 1982-11-24 |
Recalls involving this device
No recalls on record reference this clearance.