Neodent EasyGuide Kit Cases
by JJGC Indústria e Comércio de Materiais Dentários S/A.
510(k) K203618
Neodent EasyGuide Kit Cases is a Class II device made by JJGC Indústria e Comércio de Materiais Dentários S/A., cleared under FDA 510(k) K203618 on 9 Mar 2021, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK203618 | Date9 Mar 2021 | StatusActive |
Official records
- FDA 510(k) database K203618
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KCT
- FDA applicant
- Jjgc Industria E Comercio DE Materiais Dentarios S.A.
- Device class
- Class II
- Regulation
- 21 CFR Part 880.6850
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K203618
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Neodent 110.340 | 110.340 / 110.340 | 07899878064732 | Height 64 mm; Width 90 mm; Length 195 mm | On the market |
| Neodent 110.341 | 110.341 / 110.341 | 07899878064749 | Height 64 mm; Length 195 mm; Width 90 mm | On the market |
| Neodent 110.343 | 110.343 / 110.343 | 07899878064923 | Height 64 mm; Length 195 mm; Width 90 mm | On the market |
| Neodent 110.344 | 110.344 / 110.344 | 07899878064930 | Length 195 mm; Width 90 mm; Height 64 mm | On the market |
Similar devices
Other devices filed under FDA product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories).
- SURGICAL KIT KTMEC 02 by S.I.N. - Sistema DE Implante Nacional S.A.
- Safe-T-Seal by Gs Medical Packaging, Inc.
- ERMIS ER100.030E by Ermis MedTech GmbH
- SURGICAL KIT KCSWG 04 by S.I.N. - Sistema DE Implante Nacional S.A.
- Perforated Baskets by RICHARD WOLF MEDICAL INSTRUMENTS CORP.
- INSTRUSAFE IN-2600-04-EN-009 by Summit Medical, LLC
- Vis-U-All II Self Seal Pouch by STERIS CORPORATION
- Smith & Nephew Instrument Trays by Smith & Nephew Endoscopy, Inc.
- Easy Breather Header Bags by Medical Industries Packaging, Inc.
- Miltex Thompson Cassettes by Miltex, Inc.
Other devices from JJGC Indústria e Comércio de Materiais Dentários S/A.
See all devices from JJGC Indústria e Comércio de Materiais Dentários S/A. →