SUMMA DISK
FDA 510(k) clearance K833038 · decided 1983-10-04
Clearance details
- K-number
- K833038
- Device name
- SUMMA DISK
- Applicant
- Shofu Dental Corp.
- Decision
- Substantially Equivalent
- Date received
- 1983-09-06
- Decision date
- 1983-10-04
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- DZP
- Device class
- 1
- Regulation number
- 872.4535
- 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 |
|---|---|---|
| BLUWHITE DIAMOND DENTAL BURS MODIFIED (K120037) | Beavers Dental, Div. Sybron Canada, Ltd. | 2012-04-20 |
| SOPHOS DENTAL DIAMOND (K943841) | Sophos Technologic | 1994-09-16 |
| DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS (K940908) | Dunhall Pharmaceuticals, Inc. | 1994-08-29 |
| DENTAL DRILL (K934981) | Eare Consulting Service | 1994-02-03 |
| DENTAL DIAMOND DRILLS (K923757) | Alpha Industrializacao DE Metais Ltda. | 1993-03-16 |
| MANI DIA-BURS (K913651) | The Lahr Consulting Group, Inc. | 1992-01-14 |
| DENDIA WERK BURS AND CUTTING DISCS (K901967) | Micro-Aire Surgical Instruments, Inc. | 1990-07-13 |
| F.G. LASER (DENTAL BUR) (K901262) | Diamond Rotary and Carbide Intl. | 1990-07-09 |
| FG DIAMOND BURRS (K900089) | Kab Gloves Unltd. | 1990-04-03 |
| 3D DENTAL DIAMOND ROTARY INSTRUMENTS (K893844) | Lustgarten Multi-Tech International, Inc. | 1989-08-11 |
| NOVA DIAMOND (K885233) | Microcopy, Div. Neo-Flo, Inc. | 1989-02-13 |
| BEAVERS' DENTAL DIAMOND INSTRUMENTS (K880179) | Beavers Dental, Div. Sybron Canada, Ltd. | 1988-03-09 |
Recalls involving this device
No recalls on record reference this clearance.