SUPER EVACRETRACTOR, DISPOSABLE ORAL EVACUATOR
FDA 510(k) clearance K911072 · decided 1991-05-15
Clearance details
- K-number
- K911072
- Device name
- SUPER EVACRETRACTOR, DISPOSABLE ORAL EVACUATOR
- Applicant
- A & F Products
- Decision
- Substantially Equivalent
- Date received
- 1991-03-11
- Decision date
- 1991-05-15
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- EHZ
- Device class
- 1
- Regulation number
- 872.6640
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Santa Ana, CA, 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 |
|---|---|---|
| IMTEC BONE COLLECTOR SYSTEM (K973248) | Imtec Corp. | 1997-11-19 |
| TAP EXPRESS EJECTOR (K941164) | Tap Express, Inc. | 1994-05-18 |
| OROSCOPE MODEL NUMBER COS-100 (K903718) | Cygnus Instruments, Inc. | 1990-11-09 |
| DENTAL SANI-SLEEVE STERILE 100MM X 2200MM #1102 (K892882) | Nieusma R & D, Inc. | 1989-06-23 |
| DENTAL SANI-SLEEVE STERILE 60MM X 1650MM #1101 (K892881) | Nieusma R & D, Inc. | 1989-06-23 |
| DRI-CLAVE LIQUID KLEENZALL (K880754) | Columbus Dental Mfg. Co. | 1988-05-12 |
| PORTABLE FIELD DENTAL OPERATING & TREATMENT UNIT (K873545) | Commercial Products & Engineering Co. | 1987-11-20 |
| TITANIUM SUCTION TIP (K874401) | Implant Innovations International, Inc. | 1987-11-12 |
| VAC - RITE RIGHT ANGLE ASPIRATOR TUBE & HOLDER (K864621) | Seldoren , Ltd. | 1987-02-13 |
| EVACUATOR TIPS (K863769) | The Medical Group, Inc. | 1986-10-30 |
| SPACELINE HIGH VOLUME EVACUATION HANDPIE (K801682) | Pacific Dental Corp. | 1980-08-04 |
| MVS UNIT, MODEL SEU-8 AND DEU-8, 80 (K782068) | Dentsply Intl. | 1979-01-26 |
Recalls involving this device
No recalls on record reference this clearance.