510(k) K230804
- Device
- Complement Kit Cases
- Applicant
- JJGC Indústria e Comércio de Materiais Dentários S.A.
- 510(k) number
- K230804
- Product code
- KCT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-07-07
- Date received
- 2023-03-23
- Regulation
- 880.6850
- Classification name
- Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Barbara Uzae
- Address
- Av. Juscelino Kubitschek De Oliveira, 3291 Cic Curitiba BR 81270-200 81270-200
FDA Registration Numbers
- 1222780
- 3010772758
- 1056553
- 9610612
- 2919128
- 3011373951
- 3006948427
- 3014334038
- 1835444
- 1423662
- 1057421
- 3015181082
- 3013177549
- 3011575197
- 3007389669
- 2431166
- 3020584246
- 3006540014
- 3012085539
- 3001617766
- 8010177
- 3004080920
- 3003394627
- 3009307953
- 3014967149
- 3026612481
- 3011050570
- 3015537048
- 3043237009
- 2020601
- 3009110133
- 1418005
- 3010202439
- 2936485
- 2084725
- 3018094310
- 3009968482
- 3043164947
- 1421101
- 3009973505
- 3015895045
- 3008693672
- 3027345187
- 3020767943
- 3014553709
- 1043653
- 3009540749
- 1221053
- 3005083075
- 3004608878
- 3008868758
- 3001675293
- 3005741909
- 3002808270
- 3027665899
- 3006846433
- 3003990090
- 2031966
- 1032347
- 9611102
- 3008517893
- 1219930
- 8043792
- 3014003062
- 9710524
- 3013188547
- 3005282635
- 9611959
- 3002259632
- 3005004799
- 1923569
- 3008132392
- 3012055599
- 3008812560
- 3006783837
- 1319130
- 3017155536
- 9611274
- 9617111
- 1058020
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07899878061151 | Neodent | JJGC Indústria e Comércio de Materiais Dentários S/A. | 2023-08-18 |
| 07899878061144 | Nuvo | JJGC Indústria e Comércio de Materiais Dentários S/A. | 2023-08-18 |
Other 510(k) Records For Product Code KCT
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253791 | PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System Lid | DePuy Mitek, Inc. | 2026-02-26 |
| K251614 | Stainless Steel Surgical Kits | Dentsply Sirona, Inc. | 2026-02-06 |
| K251756 | Sterilization Trays | Paragon Implant Mfg., LLC | 2025-11-14 |
| K251300 | Plastic Surgical Kits | Dentsply Sirona, Inc. | 2025-07-22 |
| K243425 | Guided DAS Surgical Kit | Talladium España, SL | 2025-07-22 |
| K243589 | PAL Sterilization Case | Microaire Surgical Instruments, LLC | 2025-06-20 |
| K242762 | Aesculap Aicon® Series Container System | Aesculap, Inc. | 2025-05-13 |
| K250029 | ONE TRAY® Sealed Sterilization Container System | Innovative Sterilization Technologies | 2025-05-01 |
| K241927 | Synthes Graphic Case & Tray System | Synthes GmbH | 2025-03-28 |
| K242564 | Autoclavable Cassette (Glidewell HT Implant Guided Surgical Kit, Glidewell HT Implant Surgical Kit, Glidewell Prosthetic Kit) | Prismatik Dentalcraft, Inc. | 2025-03-21 |
| K242023 | Microdent Sterilization Cassette | Implant Microdent System S.L.U. | 2025-02-19 |
| K243317 | NUVENTUS NV.C Surgical Cassette and Tray | Infinitum Eta, Ltd. | 2025-02-11 |
| K242834 | System 9 Sterile Battery Container | Stryker Instruments | 2025-01-16 |
| K243128 | Klockner Kits | SOADCO, S.L. | 2024-12-18 |
| K241492 | Guided Surgery Kit Cases | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2024-08-23 |