510(k) K863766
- Device
- Disposable Mouth Mirrors, Single Use Only
- Applicant
- THE MEDICAL GROUP, INC.
- 510(k) number
- K863766
- Product code
- EAX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-10-30
- Date received
- 1986-09-25
- Regulation
- 872.4565
- Classification name
- Mirror, Mouth
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHUCK SMITHSON
- Address
- 4600 Kietzke Ln. L235 Reno NV US 89502 89502
FDA Registration Numbers#
- 3007255375
- 3015156396
- 3043149181
- 1215305
- 3006410968
- 3004215117
- 2127132
- 2080222
- 3003386548
- 3009703496
- 3033858988
- 3004892425
- 3003038445
- 3017910185
- 3008388427
- 3012101664
- 8010099
- 3010041511
- 3009049852
- 3008729549
- 3007284437
- 3014290918
- 3025414363
- 8040881
- 3015136927
- 9615399
- 3006235664
- 3006542501
- 3034725654
- 3013075752
- 3001620590
- 3005587147
- 3013946322
- 3026326493
- 3004096300
- 3010701675
- 3014908171
- 2126387
- 3043138885
- 3029683441
- 8040884
- 3010896988
- 1421307
- 3031564283
- 3006113202
- 8043962
- 3011164188
- 9616250
- 3011983031
- 3004992978
- 3011625373
- 1066741
- 3009211643
- 1417592
- 3008392711
- 3013508670
- 3019404837
- 3011499367
- 3015357315
- 3003334541
- 3009827000
- 3021023132
- 3007113232
- 2246990
- 3009926836
- 3015272949
- 3017609565
- 3010155661
- 3010669020
- 3015512299
- 3002769835
- 3003444492
- 3008887731
- 3005809810
- 3016798774
- 3004569445
- 9680002
- 3007064566
- 3008005217
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EAX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K946073 | ORALVUE DENTAL MIRROR | Hines Group , Ltd. | 1995-02-16 |
| K935906 | RANIR PLAX RX | Ranir/Dcp Corp. | 1994-09-02 |
| K941574 | RETRO MIRROR | Union Broach, Div. Moyco Industries, Inc. | 1994-05-18 |
| K935687 | NIL | Dentalsafe Systems Pty., Ltd. | 1994-02-03 |
| K863767 | GLASS MOUTH MIRRORS, REUSABLE | The Medical Group, Inc. | 1986-10-30 |
| K833310 | FOGCUTTER DENTAL MOUTH MIRROR | Hti, Inc. | 1984-05-07 |
| K841199 | FIBERGLASS MOUTH MIRRORS | Henry Schein, Inc. | 1984-04-25 |
| K833429 | PERI MIRROR/SALIVA EJECTOR | Dentec, Inc. | 1983-12-22 |
| K830777 | ELECTRIC MOUTH MIRROR | Almore Intl., Inc. | 1983-04-06 |
| K821777 | BEACH MOUTH MIRROR | Pacific Dental Corp. | 1982-07-06 |
| K800919 | ORAVIEW BY WATER PIK | Teledyne, Inc. | 1980-05-08 |