510(k) K181142
- Device
- Absoanchor Microimplant
- Applicant
- Dentos Inc
- 510(k) number
- K181142
- Product code
- OAT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-02-05
- Date received
- 2018-05-01
- Regulation
- 872.3640
- Classification name
- Implant, Endosseous, Orthodontic
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kim Jin-Hyun
- Address
- 41, Seongseo-Ro 68-Gil, Dalseo-Gu Daegu KR 42697 42697
FDA Registration Numbers#
- 8043792
- 1032347
- 3009732568
- 3011302692
- 3008323540
- 3014270297
- 3016543896
- 3012396434
- 3007515069
- 2031093
- 3010407203
- 3022296393
- 1424785
- 9614404
- 3005914490
- 3013508670
- 3005562917
- 3015440604
- 3004730002
- 3013034344
- 3012477813
- 3034676720
- 3007738812
- 3018070878
- 3013689189
- 1424263
- 3003394081
- 8044058
- 3008812251
- 3008812560
- 3015272949
- 3043841530
- 3010596333
- 2032098
- 3005728057
- 3008559295
- 9613348
- 3003402534
- 9681207
- 9680963
- 3031886796
- 3011530718
- 3017125693
- 3008524225
- 3004049923
- 3001561923
- 3004158247
- 3015399803
- 3005515228
- 3004203816
- 3008261720
- 3006034256
- 3013701115
- 9611458
Source Documents#
510(k) summary PDF not indicated by FDA
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| K201919 | Blue Sky Bio TAD | Blue Sky Bio, LLC | 2020-12-17 |
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| K190871 | Bio-TackS Orthodontic Mini Implant | Biocetec Co., Ltd. | 2020-01-17 |
| K182929 | BIO-RAY A-1 Anchor Screw System | Microware Precision Co., Ltd. | 2019-11-06 |