510(k) K830777
- Device
- ELECTRIC MOUTH MIRROR
- Applicant
- ALMORE INTL., INC.
- 510(k) number
- K830777
- Product code
- EAX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-04-06
- Date received
- 1983-03-11
- 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#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3011164188
- 1051614
- 3003244954
- 2029234
- 3010442693
- 3033858988
- 3004892425
- 3043648115
- 3010583458
- 3002911411
- 1219113
- 3043226252
- 3010455030
- 3009703496
- 3009827000
- 1833132
- 3023339277
- 9611503
- 3015512299
- 3008936260
- 3002090132
- 2133714
- 3043149181
- 3008388427
- 8040233
- 3003882387
- 3030644259
- 3004704962
- 3007353764
- 3004417597
- 3015176311
- 3009968482
- 9614075
- 3043088937
- 1319147
- 3049552730
- 2024949
- 3033011342
- 3014615697
- 3003582728
- 3000279801
- 3029683441
- 3009142030
- 3002808270
- 3002807120
- 3024787345
- 1421101
- 3011554142
- 9681540
- 3011707926
- 9615399
- 3005194291
- 3004193466
- 3005809810
- 3009926836
- 3013508670
- 3004598675
- 3024088964
- 2126387
- 3044819802
- 3012101664
- 3027556548
- 8010445
- 3006608997
- 3009171220
- 3006113202
- 3005951403
- 9680518
- 2029275
- 3001297506
- 3005177644
- 1056350
- 3013075752
- 1421879
- 3049848767
- 3010610239
- 3006536571
- 3003032798
- 3010032042
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 |
| K863766 | DISPOSABLE MOUTH MIRRORS, SINGLE USE ONLY | The Medical Group, Inc. | 1986-10-30 |
| 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 |
| K821777 | BEACH MOUTH MIRROR | Pacific Dental Corp. | 1982-07-06 |
| K800919 | ORAVIEW BY WATER PIK | Teledyne, Inc. | 1980-05-08 |
Legacy Summary#
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FDA Review#
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