510(k) K193066
- Device
- Steripack Cases And Tray Systems
- Applicant
- Avalign Technologies, Inc.
- 510(k) number
- K193066
- Product code
- KCT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-08-06
- Date received
- 2019-11-04
- 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
- Hiren Patel
- Address
- 8727 Clinton Park Dive Fort Wayne IN US 46825 46825
FDA Registration Numbers#
- 3004201263
- 3021336392
- 3003990090
- 1423662
- 3015967359
- 9612468
- 3008693672
- 1421101
- 9616096
- 1053306
- 2027467
- 1221934
- 1834379
- 3017619652
- 1450428
- 3005360851
- 3007487007
- 1836161
- 1526534
- 1030489
- 8010697
- 3014191428
- 3004464325
- 3009110133
- 3043543260
- 9680845
- 3011276344
- 1226230
- 3008868758
- 2081135
- 3020331900
- 8010177
- 1320894
- 3036622014
- 3006113180
- 3016555232
- 8044099
- 3043226252
- 3009050824
- 3008132392
- 3004193466
- 1418479
- 1057421
- 2434839
- 3004153240
- 3012627460
- 1222780
- 3011795235
- 9680718
- 1056350
- 1319130
- 1221053
- 3027345187
- 3003477135
- 3009973505
- 9617111
- 2435946
- 3010393565
- 3009719225
- 3015181082
- 3010687973
- 3003230618
- 1935627
- 8030674
- 1835444
- 3022626486
- 3014579188
- 3005409899
- 9613277
- 1221763
- 1058584
- 2518634
- 8010099
- 3015895145
- 3004203816
- 3005369776
- 3003120897
- 3009513193
- 1923569
- 3011050570
Source Documents#
Other 510(k) Records For Product Code KCT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253988 | LiteSet Trays | Nobel Biocare AB | 2026-09-08 |
| K261935 | Surgical and Prosthetic Trays | Dentsply Sirona, Inc. | 2026-09-04 |
| 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 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases