Instrument kits
FDA 510(k) K160730 · Anthogyr
510(k) numberK160730
Submission
- Device name
- Instrument kits
- Applicant
- Anthogyr
Sallanches, FR - Received
- March 16, 2016
- Decision date
- April 27, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KCT – Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6850
- Specialty
- General Hospital
Other 510(k)s with product code KCT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253988 | LiteSet TraysKCT · Traditional | Nobel Biocare AB | 09/08/2026SE |
| K261935 | Surgical and Prosthetic TraysKCT · Traditional | Dentsply Sirona, Inc. | 09/04/2026SE |
| K253187 | SteriBest® Sterilization Tray SystemKCT · Traditional | Mastel Surgical | 06/18/2026SE |
| K260726 | Straumann® ProClean Cassette (041.800 ; 041.801)KCT · Traditional | Institut Straumann AG | 06/03/2026SE |
| K252854 | SteriTite Container System with MediTray ProductsKCT · Traditional | Case Medical, Inc. | 06/03/2026SE |
| K253791 | PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System LidKCT · Traditional | DePuy Mitek, Inc. | 02/26/2026SE |
| K251614 | Stainless Steel Surgical KitsKCT · Traditional | Dentsply Sirona, Inc. | 02/06/2026SE |
| K251756 | Sterilization TraysKCT · Traditional | Paragon Implant Mfg., LLC | 11/14/2025SE |
| K251300 | Plastic Surgical KitsKCT · Traditional | Dentsply Sirona, Inc. | 07/22/2025SE |
| K243425 | Guided DAS Surgical KitKCT · Traditional | Talladium España, SL | 07/22/2025SE |
More from Talladium España, SL
| 510(k) | Device | Decision |
|---|---|---|
| K231072 | Anthogyr FlexiBase® titanium bases for Axiom® BLNHA · Traditional | 01/04/2024SE |
| K233264 | Anthogyr INTEGRAL Guided Surgery CassettesKCT · Traditional | 12/22/2023SE |
| K230104 | Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLDZE · Traditional | 10/16/2023SE |
| K230680 | Anthogyr Surgical CassettesKCT · Traditional | 07/11/2023SE |
| K161177 | Axiom PXDZE · Abbreviated | 06/15/2017SE |
| K141450 | Axiom 2.8DZE · Abbreviated | 09/17/2014SE |
| K131066 | Axiom RegDZE · Traditional | 02/21/2014SE |
| K111532 | Montblanc Surgical Contra-Angle and Straight HandpieceEGS · Traditional | 10/07/2011SE |
| K102241 | Anthogyr Implanteo Implantology and Dental Surgical Motor UnitEBW · Traditional | 03/23/2011SE |
| K101913 | Anthofit Oi, Anthofit He, Ossfit and AxiomDZE · Abbreviated | 03/11/2011SE |
Questions and answers
When was Instrument kits cleared by the FDA?
Instrument kits (K160730) received a 510(k) decision of Substantially Equivalent on April 27, 2017, 407 days after the submission was received.
What is the product code of K160730?
The FDA product code is KCT – Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, a Class II (moderate risk) device regulated under 21 CFR 880.6850.