Neodent Implant System-Helix NGM Compact Surgical Kit Cases
FDA 510(k) K214051 · JJGC Indústria e Comércio de Materiais Dentários S.A.
510(k) numberK214051
Submission
- Device name
- Neodent Implant System-Helix NGM Compact Surgical Kit Cases
- Applicant
- JJGC Indústria e Comércio de Materiais Dentários S.A.
Curitiba, BR - Received
- December 27, 2021
- Decision date
- April 13, 2022
- 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 |
|---|---|---|
| K261147 | Neodent Implant System - NeoConvert FitNHA · Traditional | 07/01/2026SE |
| K253922 | Neodent Scannable Healing AbutmentNHA · Traditional | 06/15/2026SE |
| K252727 | Neodent InLab Validated WorkflowNHA · Traditional | 01/07/2026SE |
| K252090 | Pterygoid Indication for GM Helix ImplantsDZE · Traditional | 12/12/2025SE |
| K250271 | Neodent Implant System - Zirconia Implant SystemDZE · Traditional | 08/18/2025SE |
| K241492 | Guided Surgery Kit CasesKCT · Traditional | 08/23/2024SE |
| K233857 | Neodent Implant System Custom AbutmentsNHA · Traditional | 05/02/2024SE |
| K231803 | Neodent Implant System - Zirconia Implant SystemNHA · Traditional | 12/13/2023SE |
| K232099 | Neodent Implant System - GM Zygomatic Implant SystemDZE · Traditional | 10/31/2023SE |
| K230804 | Complement Kit CasesKCT · Traditional | 07/07/2023SE |
Questions and answers
When was Neodent Implant System-Helix NGM Compact Surgical Kit Cases cleared by the FDA?
Neodent Implant System-Helix NGM Compact Surgical Kit Cases (K214051) received a 510(k) decision of Substantially Equivalent on April 13, 2022, 107 days after the submission was received.
What is the product code of K214051?
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.