NIL
FDA 510(k) clearance K935687 · decided 1994-02-03
Clearance details
- K-number
- K935687
- Device name
- NIL
- Applicant
- Dentalsafe Systems Pty., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1993-11-29
- Decision date
- 1994-02-03
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- EAX
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Sydney, Australia, AU
- 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 |
|---|---|---|
| ORALVUE DENTAL MIRROR (K946073) | Hines Group , Ltd. | 1995-02-16 |
| RANIR PLAX RX (K935906) | Ranir/Dcp Corp. | 1994-09-02 |
| RETRO MIRROR (K941574) | Union Broach, Div. Moyco Industries, Inc. | 1994-05-18 |
| GLASS MOUTH MIRRORS, REUSABLE (K863767) | The Medical Group, Inc. | 1986-10-30 |
| DISPOSABLE MOUTH MIRRORS, SINGLE USE ONLY (K863766) | The Medical Group, Inc. | 1986-10-30 |
| FOGCUTTER DENTAL MOUTH MIRROR (K833310) | Hti, Inc. | 1984-05-07 |
| FIBERGLASS MOUTH MIRRORS (K841199) | Henry Schein, Inc. | 1984-04-25 |
| PERI MIRROR/SALIVA EJECTOR (K833429) | Dentec, Inc. | 1983-12-22 |
| ELECTRIC MOUTH MIRROR (K830777) | Almore Intl., Inc. | 1983-04-06 |
| BEACH MOUTH MIRROR (K821777) | Pacific Dental Corp. | 1982-07-06 |
| ORAVIEW BY WATER PIK (K800919) | Teledyne, Inc. | 1980-05-08 |
Recalls involving this device
No recalls on record reference this clearance.