510(k) K160730
- Device
- Instrument Kits
- Applicant
- ANTHOGYR
- 510(k) number
- K160730
- Product code
- KCT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-04-27
- Date received
- 2016-03-16
- 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
Applicant Contact#
- Contact
- Therese CANDAU
- Address
- 2237 Ave. Andre Lasquin Sallanches FR 74700 74700
FDA Registration Numbers#
- 2249529
- 3016607092
- 9680735
- 2020601
- 1017294
- 3013557562
- 3005369776
- 9617542
- 8030674
- 3008864603
- 1057421
- 3006846433
- 1056350
- 3010041430
- 3020331900
- 3005741909
- 9610773
- 1056553
- 3009307953
- 3012494290
- 3015392401
- 3010157088
- 2936485
- 3011063460
- 9610617
- 3009968482
- 1526531
- 1056276
- 2020550
- 1720499
- 3012236936
- 3009538923
- 9710524
- 3003230618
- 3023155873
- 3005083075
- 1030489
- 3003990090
- 1032347
- 2434839
- 9611992
- 1062741
- 2134470
- 3012627460
- 2024312
- 3013114075
- 8020776
- 3004112448
- 9611102
- 8040233
- 1835251
- 3012055599
- 1834379
- 3013247477
- 1834331
- 3012085539
- 3043543260
- 2518634
- 3012421607
- 3004201263
- 1221053
- 8030607
- 3010393565
- 3014421917
- 3005900820
- 8044099
- 3022626486
- 9612468
- 3014615028
- 1416980
- 8043971
- 3000270450
- 3011649314
- 3011795235
- 1058584
- 1941138
- 3011050570
- 3004193466
- 3008791019
- 3013283620
Source Documents#
Other 510(k) Records For Product Code KCT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253187 | SteriBest® Sterilization Tray System | Mastel Surgical | 2026-06-18 |
| K252854 | SteriTite Container System with MediTray Products | Case Medical, Inc. | 2026-06-03 |
| K260726 | Straumann® ProClean™ Cassette (041.800 ; 041.801) | Institut Straumann AG | 2026-06-03 |
| 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 |
| K243425 | Guided DAS Surgical Kit | Talladium España, SL | 2025-07-22 |
| K251300 | Plastic Surgical Kits | Dentsply Sirona, Inc. | 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 |
Legacy Summary#
summary
FDA Review#
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