510(k) K851454
- Device
- A-company Stainless Steel Orthodontic Brackets
- Applicant
- A COMPANY, INC.
- 510(k) number
- K851454
- Product code
- ECQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-04-29
- Date received
- 1985-04-11
- Regulation
- 872.4565
- Classification name
- Aligner, Bracket, Orthodontic
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOE MONFREDO
- Address
- 11436 Sorrento Valley Rd. Post Office Box 81247 San Diego CA US 92138 92138
FDA Registration Numbers#
- 9614069
- 3007165189
- 3042902614
- 3033492726
- 3030680214
- 3035484470
- 1051614
- 3014749460
- 3017618900
- 3031582434
- 3034693059
- 2081322
- 3003582728
- 3013342228
- 3013645257
- 3012771684
- 3017591226
- 1000439711
- 2246990
- 3021023132
- 1937100
- 3009171220
- 3015272949
- 3011191212
- 3022296393
- 1815540
- 3007616048
- 8043622
- 3038718579
- 3025358043
- 3039441248
- 3032027578
- 9680002
- 3007962015
- 3010288346
- 3018258389
- 3017155477
- 3013463240
- 3001561923
- 3015432501
- 3009340886
- 3024787345
- 9611458
- 3010598169
- 3005728058
- 3007504672
- 3009420946
- 3002769844
- 3044462786
- 3008887731
- 3016543896
- 3009955691
- 3003963832
- 3008352964
- 8041151
- 1833132
- 3007284437
- 3015266919
- 3014270297
- 3015353992
- 3003877407
- 3004003391
- 3003700106
- 3009827000
- 3014326245
- 3013556527
- 3030234169
- 3008005217
- 9680845
- 3013600135
- 3011585752
- 3010032042
- 3014701704
- 3005092287
- 3010227586
- 3031606517
- 3012477813
- 3031570897
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ECQ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K935153 | DENTAURUM BRACKET POSITIONING GAUGE | Dentauraum, Inc. | 1994-01-31 |