envisiontec.comSimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230)
Envision Endoscopy
Envista (Suzhou) Medical Device Co., Ltd.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3014749460 | 3014749460 | Envista (Suzhou) Medical Device Co., Ltd. | 1 | N | 2026-01-01 | 1st floor 2nd floor Building 18#, No.8 Jinfeng Road Suzhou Jiangsu CN 215163 |
| 3021551844 | 3021551844 | ENVISION ENDOSCOPY INC. | 1 | N | 2026-01-01 | 204 Second Ave Waltham MA US 02451 |
| 3045923493 | 3045923493 | Envista (Suzhou) Medical Device Co., Ltd. | 1 | N | 2026-01-01 | Unit D03, D04 of Building 19 and Unit E01 of Building 20 No. 122 Yong'an Road, Suzhou High-tech Zone Suzhou Jiangsu CN 215151 |
| 0 | 0 | ENVISION ENERGY CO., LTD | 5 | N | 2020-04-25 | No.3 Shenzhuang Road, Jiangyin Wuxi Jiangsu CN 214400 |
| 3009261582 | 3009261582 | EnvisionTEC Inc. | 1 | Y | 2020-04-25 | 15162 S Commerce Dr Dearborn MI US 48120 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 04260683220041 | E-Guard Blue - E-Guard Blue is a light-curing material for the additive manufacturing of individual dental bite splints | +49204398750 | info@envisiontec.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 351349 | 2005049571 | K243750 | SimpleStitch Suturing System | OCW | 2025-04-17 |
| 351349 | 1915062675 | K242923 | SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230) | OCZ | 2024-12-20 |
| 202599 | 1619211114 | ||||
| 249132 | 1926877547 | ||||
| 202599 | 2043731527 | ||||
| 291536 | 1303563594 | ||||
| 350698 | 1303563594 | ||||
| 350698 | 1330944091 | ||||
| 291536 | 1330944091 | ||||
| 350698 | 1453048818 | ||||
| 291536 | 1453048818 | ||||
| 291536 | 1486609531 | ||||
| 350698 | 1486609531 | ||||
| 291536 | 1668530861 | ||||
| 350698 | 1668530861 | ||||
| 291536 | 1835048545 | ||||
| 350698 | 1835048545 |
Product Codes Associated With Registrations#
PMN#
Radify Triage
Envisionit Deepai, Ltd.
SmileGuard
EnvisionTEC GmbH
E-Temp
Envisiontec GmbH
E-Dent 1000
EnvisionTEC GmbH
E-Denture Pro
EnvisionTEC GmbH
E-Guard
EnvisionTEC GmbH
TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE
ENVISIONEERING, LLC.
TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM
ENVISIONEERING, LLC.
TARGETSCAN BIOPSY KIT
Envisioneering, LLC
TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM
ENVISIONEERING, LLC.
ELRAN 01 SYSTEM
ENVISION ADVANCED MEDICAL SYSTEM LTD
AROMAPATCH
ENVIS, INC.
3-CCD DIGITAL CAMERA
ENVISION MEDICAL CORP.
SURGICAL INTEGRATED CAMERA SYSTEM
ENVISION MEDICAL CORP.
XENON LIGHT SOURCE
ENVISION MEDICAL CORP.
ENVISION ARTHROSCOPY VISUALIZATION SYSTEM
ENVISION SURGICAL SYSTEM, INC.
ENVISION ARTHROSCOPE, CANNULA,TROCAR, OBTURATOR, AND PROBE
ENVISION SURGICAL SYSTEM, INC.
ENVISION ARTHROSCOPY SYSTEM
ENVISION SURGICAL SYSTEM, INC.
ISOLATED CAMERA HEAD
ENVISION MEDICAL CORP.
CAMERA, SURGICAL AND ACCESSORIES
ENVISION MEDICAL CORP.
ENVISION G31 P.E. PAK
ENVISION, INC.
ENVISION G21 I/A ENPAK
ENVISION, INC.
GUDID#
E-Guard - E-Guard is a light-curing material for the additive manufacturing of individual dental bite splints.
2020-12-02
E-Guard Blue - E-Guard Blue is a light-curing material for the additive manufacturing of individual dental bite splints
2020-12-17
SmileGuard - SmileGuard is a light-curing material for the additive manufacuring of flexible, individual dental bite splints.
2022-08-19
Flexcera Base Ultra+ Dark Meharry - Flexcera Base Ultra+ is a light-curing material for the additive manufacturing of individual and removable full and partial denture bases
2023-09-13
Flexcera Base Ultra+ Light Pink - Flexcera Base Ultra+ is a light-curing material for the additive manufacturing of individual and removable full and partial denture bases
2023-09-13
Flexcera™ Base Ultra+ Dark Pink - Flexcera Base Ultra+ is a light-curing material for the additive manufacturing of individual and removable full and partial denture bases
2023-09-13
Flexcera™ Base Ultra+ Medium Pink - Flexcera Base Ultra+ is a light-curing material for the additive manufacturing of individual and removable full and partial denture bases
2023-09-13
Flexcera Base Ultra+ Pink - Flexcera Base Ultra+ is a light-curing material for the additive manufacturing of individual and removable full and partial denture bases
2023-09-13
Flexcera™ Smile Ultra+ for Carbon® Printers B1 - Flexcera™ Smile Ultra+ for Carbon® Printers is a light-curing material for the additive manufacturing of permanent single and partialcrowns, of artificial teeth, of veneers and of monolithic full and partial dentures and temporary crowns and bridges.
2023-08-02
Flexcera™ Smile Ultra+ for Carbon® Printers A2 - Flexcera™ Smile Ultra+ for Carbon® Printers is a light-curing material for the additive manufacturing of permanent single and partialcrowns, of artificial teeth, of veneers and of monolithic full and partial dentures and temporary crowns and bridges.
2023-08-02
Flexcera™ Smile Ultra+ for Carbon® Printers A1 - Flexcera™ Smile Ultra+ for Carbon® Printers is a light-curing material for the additive manufacturing of permanent single and partialcrowns, of artificial teeth, of veneers and of monolithic full and partial dentures and temporary crowns and bridges.
2023-08-02
Flexcera™ Smile Ultra+ for Carbon® Printers Bleach - Flexcera™ Smile Ultra+ for Carbon® Printers is a light-curing material for the additive manufacturing of permanent single and partialcrowns, of artificial teeth, of veneers and of monolithic full and partial dentures and temporary crowns and bridges.
2023-08-02
Flexcera™ Smile Ultra+ Bleach 0.5kg - Flexcera™ Smile Ultra+ is a light-curing material for the additive manufacturing of permanent single and partial crowns, of artificial teeth, of veneers and of monolithic full and partial dentures and temporary crowns and bridges.
2022-01-21
Flexcera™ Smile Ultra+ B1 0.5kg - Flexcera™ Smile Ultra+ is a light-curing material for the additive manufacturing of permanent single and partial crowns, of artificial teeth, of veneers and of monolithic full and partial dentures and temporary crowns and bridges.
2022-01-21
Flexcera™ Smile Ultra+ A3.5 0.5kg - Flexcera™ Smile Ultra+ is a light-curing material for the additive manufacturing of permanent single and partial crowns, of artificial teeth, of veneers and of monolithic full and partial dentures and temporary crowns and bridges.
2022-01-21
Flexcera™ Smile Ultra+ A3 0.5kg - Flexcera™ Smile Ultra+ is a light-curing material for the additive manufacturing of permanent single and partial crowns, of artificial teeth, of veneers and of monolithic full and partial dentures and temporary crowns and bridges.
2022-01-21
Flexcera™ Smile Ultra+ A2 0.5kg - Flexcera™ Smile Ultra+ is a light-curing material for the additive manufacturing of permanent single and partial crowns, of artificial teeth, of veneers and of monolithic full and partial dentures and temporary crowns and bridges.
2022-01-21
Flexcera™ Smile Ultra+ A1 0.5kg - Flexcera™ Smile Ultra+ is a light-curing material for the additive manufacturing of permanent single and partial crowns, of artificial teeth, of veneers and of monolithic full and partial dentures and temporary crowns and bridges.
2022-01-21
Flexcera™ Smile Ultra+ Bleach - Flexcera™ Smile Ultra+ is a light-curing material for the additive manufacturing of permanent single and partial crowns, of artificial teeth, of veneers and of monolithic full and partial dentures and temporary crowns and bridges.
2022-01-21
Flexcera™ Smile Ultra+ B1 - Flexcera™ Smile Ultra+ is a light-curing material for the additive manufacturing of permanent single and partial crowns, of artificial teeth, of veneers and of monolithic full and partial dentures and temporary crowns and bridges.
2022-01-21
Flexcera™ Smile Ultra+ A3.5 - Flexcera™ Smile Ultra+ is a light-curing material for the additive manufacturing of permanent single and partial crowns, of artificial teeth, of veneers and of monolithic full and partial dentures and temporary crowns and bridges.
2022-01-21
Flexcera™ Smile Ultra+ A3 - Flexcera™ Smile Ultra+ is a light-curing material for the additive manufacturing of permanent single and partial crowns, of artificial teeth, of veneers and of monolithic full and partial dentures and temporary crowns and bridges.
2022-01-21
Flexcera™ Smile Ultra+ A2 - Flexcera™ Smile Ultra+ is a light-curing material for the additive manufacturing of permanent single and partial crowns, of artificial teeth, of veneers and of monolithic full and partial dentures and temporary crowns and bridges.
2022-01-21
Flexcera™ Smile Ultra+ A1 - Flexcera™ Smile Ultra+ is a light-curing material for the additive manufacturing of permanent single and partial crowns, of artificial teeth, of veneers and of monolithic full and partial dentures and temporary crowns and bridges.
2022-01-21
Flexcera Smile Bleach - Flexcera Smile is a light-curing material for the additive manufacturing of artificial teeth for denture bases.
2021-04-19
Flexcera Smile B1 - Flexcera Smile is a light-curing material for the additive manufacturing of artificial teeth for denture bases.
2021-04-19
Flexcera Smile A3.5 - Flexcera Smile is a light-curing material for the additive manufacturing of artificial teeth for denture bases.
2021-04-19
Flexcera Smile A3 - Flexcera Smile is a light-curing material for the additive manufacturing of artificial teeth for denture bases.
2021-04-19
Flexcera Smile A2 - Flexcera Smile is a light-curing material for the additive manufacturing of artificial teeth for denture bases.
2021-04-19
Flexcera Smile A1 - Flexcera Smile is a light-curing material for the additive manufacturing of artificial teeth for denture bases.
2021-04-19
Flexcera Base Dark Meharry - Flexcera Base is a light-curing material for the additive manufacturing of individual and removable full denture bases
2021-05-06
Flexcera Base Light Pink - Flexcera Base is a light-curing material for the additive manufacturing of individual and removable full denture bases
2021-05-06
Flexcera Base Dark Pink - Flexcera Base is a light-curing material for the additive manufacturing of individual and removable full denture bases
2021-05-06
Flexcera Base Medium Pink - Flexcera Base is a light-curing material for the additive manufacturing of individual and removable full denture bases
2021-05-06
Flexcera Base Original Pink - Flexcera Base is a light-curing material for the additive manufacturing of individual and removable full denture bases
2021-05-06
E-Guide Soft - E-Guide Soft is a light-curing material for the additive manufacturing of nasopharyngeal and oropharyngeal swabs
2020-10-07
E-Tray - E-Tray is a light-curing material for the additive manufacturing of individual dental impression trays and bite template bases
2020-10-07
E-Guide - E-Guide is a light-curing material for the additive manufacturing of individual dental surgical drill guides
2020-08-11
E-Guide - E-Guide is a light-curing material for the additive manufacturing of individual dental surgical drill guides
2020-08-11