510(k) K110898
- Device
- S.C.O.R.E.S. UNIT
- Applicant
- AMMED SURGICAL EQUIPMENT, LLC
- 510(k) number
- K110898
- Product code
- KCT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-07-26
- Date received
- 2011-03-30
- 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
- DAVID C FURR
- Address
- 8708 Capehart Cove Austin TX US 78733 78733
FDA Registration Numbers#
- 2435946
- 3010057495
- 1421879
- 3015967359
- 2023811
- 3006742481
- 3005497913
- 3010772758
- 3011063460
- 9611102
- 3006540014
- 3043543260
- 1222780
- 3015746537
- 3006783837
- 1058020
- 3002259632
- 3005694091
- 8020776
- 3007487007
- 3008791019
- 2184066
- 3008719017
- 3011533888
- 1834379
- 3014553709
- 3009968482
- 1418005
- 2024312
- 3011649314
- 3015612252
- 3004976965
- 3012322232
- 3006948427
- 1720499
- 3017949824
- 1219602
- 3013557562
- 2936485
- 2020394
- 3003394627
- 3003236702
- 3034676720
- 3011050570
- 3004112448
- 3010041511
- 3010120135
- 3020331900
- 3013177549
- 9612468
- 1053306
- 2031966
- 3010885402
- 3003120897
- 3009959868
- 3022626486
- 3013247477
- 9617542
- 3011824442
- 3017820152
- 3005360851
- 8030607
- 1043653
- 3003935342
- 1526531
- 3012055599
- 1417592
- 8030674
- 3007389669
- 3010493171
- 3011137372
- 1416980
- 1421101
- 1319130
- 3010363542
- 3010707607
- 3009513193
- 1418479
- 3026593233
- 3014579188
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#
summary
FDA Review#
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