510(k) K231079

Device: LW Retraction Cap
Applicant: Ossvis Co., Ltd.
510(k) number: K231079
Product code: NHA
Decision: Substantially Equivalent (SESE)
Decision date: 2023-09-14
Date received: 2023-04-17
Regulation: 872.3630
Classification name: Abutment, Implant, Dental, Endosseous
Medical specialty: Dental
Review panel: Dental
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: N

Related Records

Applicant Contact

Contact: Young Jae Kim
Address: 7f And B1, 38, Burim-Ro 170beon-Gil, Dongan-Gu Anyang-Si KR 14055 14055

FDA Registration Numbers

1450662
3031025053
1222315
9612300
3006473685
2027062
2183744
3012172055
3023852420
3016447764
3008770646
3005290844
3004966444
3014142650
3007842672
3012422333
3014118611
3002807112
3013111692
1038806
3021964955
3005674514
3030690317
2918719
3007728094
3010303805
3024858450
3009528809
9614705
3009756327
3030488649
3003618527
3011221537
3024852742
3009761487
3009847764
3004417597
1000244346
3004198398
3001082453
3009632672
3013547803
3005663340
8010591
1222802
3033708818
3004883837
3009528826
3035532393
3008870565
3005512166
3013102320
3006592743
3014596751
3019793783
3007740664
1054986
3017833095
9614404
9612352
3008186372
3010287685
3004578807
3009727738
3008252251
3013960655
3036779616
3007515069
3006017180
3023535580
3013701115
3014938434
1627417
3010393542
2029275
1221541
9680605
3012481042
3005739655

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DI	Brand	Company	Published
08809918245563	LW Vis Abutment SET	Ossvis Co., Ltd.	2023-12-21
08809918245624	LW Vis Abutment SET	Ossvis Co., Ltd.	2023-12-21
08809918245464	LW Vis Abutment SET	Ossvis Co., Ltd.	2023-12-21
08809918245389	LW Vis Abutment SET	Ossvis Co., Ltd.	2023-12-21
08809918245341	LW Vis Abutment SET	Ossvis Co., Ltd.	2023-12-21
08809918237230	LW Vis Abutment SET	Ossvis Co., Ltd.	2023-12-21
08809918245372	LW Vis Abutment SET	Ossvis Co., Ltd.	2023-12-21
08809918245457	LW Vis Abutment SET	Ossvis Co., Ltd.	2023-12-21
08809918245419	LW Vis Abutment SET	Ossvis Co., Ltd.	2023-12-21
08809918245396	LW Vis Abutment SET	Ossvis Co., Ltd.	2023-12-21
08809918245617	LW Vis Abutment SET	Ossvis Co., Ltd.	2023-12-21
08809918245532	LW Vis Abutment SET	Ossvis Co., Ltd.	2023-12-21
08809918245495	LW Vis Abutment SET	Ossvis Co., Ltd.	2023-12-21
08809918245471	LW Vis Abutment SET	Ossvis Co., Ltd.	2023-12-21
08809918245525	LW Vis Abutment SET	Ossvis Co., Ltd.	2023-12-21
08809918245600	LW Vis Abutment SET	Ossvis Co., Ltd.	2023-12-21
08809918245587	LW Vis Abutment SET	Ossvis Co., Ltd.	2023-12-21
08809918245549	LW Vis Abutment SET	Ossvis Co., Ltd.	2023-12-21
08809918245440	LW Vis Abutment SET	Ossvis Co., Ltd.	2023-12-21
08809918245358	LW Vis Abutment SET	Ossvis Co., Ltd.	2023-12-21
08809918245334	LW Vis Abutment SET	Ossvis Co., Ltd.	2023-12-21
08809918245426	LW Vis Abutment SET	Ossvis Co., Ltd.	2023-12-21
08809918245594	LW Vis Abutment SET	Ossvis Co., Ltd.	2023-12-21
08809918245501	LW Vis Abutment SET	Ossvis Co., Ltd.	2023-12-21
08809918245488	LW Vis Abutment SET	Ossvis Co., Ltd.	2023-12-21
08809918245570	LW Vis Abutment SET	Ossvis Co., Ltd.	2023-12-21
08809918245402	LW Vis Abutment SET	Ossvis Co., Ltd.	2023-12-21
08809918245365	LW Vis Abutment SET	Ossvis Co., Ltd.	2023-12-21
08809918245556	LW Vis Abutment SET	Ossvis Co., Ltd.	2023-12-21
08809918245518	LW Vis Abutment SET	Ossvis Co., Ltd.	2023-12-21

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