FDA.report

SURGICAL KIT ECHOPLAN PRO

Primary DI
D7701350223
Brand
SURGICAL KIT ECHOPLAN PRO
Company
SWEDEN & MARTINA SPA
Model
ZGS-PRO-S-INT
Catalog number
ZGS-PRO-S-INT
Device description
SURGICAL KIT ECHOPLAN PRO TAPERED FORM, GUIDED SURGERY
Published
2018-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D7701350223PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental implant/prosthesis surgical procedure kitA collection of various dental instruments designed for the surgical placement of dental implants or prostheses. It does not contain pharmaceuticals. It typically contains various dental drills (drill bits), drill extensions, depth gauges, wrenches and torque wrench, screwdrivers, forceps, trays and osteotomes. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
844.862.7846info.us@sweden-martina.com

Regulatory Flags

DUNS number
433815198
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
D7702749733MASTER SLEEVEGS-B-50WGS-B-50W2025-12-16
D7702749743MASTER SLEEVEGS-B-50W-6GS-B-50W-62025-12-16
D7702749753MASTER SLEEVEGS-B-50W-SETGS-B-50W-SET2025-12-16
D7702707123STARTER PACK B4USTARTER-PACK-B4U.STARTER-PACK-B4U.2025-09-26
D7701556003PRAMA RF IMPLANT ZIRTILS-ZT-380SL-180LS-ZT-380SL-1802025-08-04
D7701556073PRAMA RF IMPLANT ZIRTILS-ZT-425SL-180LS-ZT-425SL-1802025-08-04
D7701609403STOP FOR CONICAL DRILL STOP-2025-180-SWSTOP-2025-180-SW2025-07-24
D7701609413STOP FOR CONICAL DRILL STOP-2025-190-SWSTOP-2025-190-SW2025-07-24
D7701609433STOP FOR CONICAL DRILL STOP-2025-210-SWSTOP-2025-210-SW2025-07-24
D7701609443STOP FOR CONICAL DRILL STOP-2025-220-SWSTOP-2025-220-SW2025-07-24
D7701609463STOP FOR CONICAL DRILL STOP-2025-240-SWSTOP-2025-240-SW2025-07-24
D7701609483STOP FOR CONICAL DRILL STOP-2025-260-SWSTOP-2025-260-SW2025-07-24
D7701609513CYLINDRICAL DRILLFP-200-L-SWFP-200-L-SW2025-07-24
D7701609523CONICAL DRILLFK250-L-SWFK250-L-SW2025-07-24
D7701609693FINAL CONICAL DRILLFK380-L-SWFK380-L-SW2025-07-24
D7701609703FINAL CONICAL DRILLFK425-L-SWFK425-L-SW2025-07-24
D7701609733STOP FOR CONICAL DRILL STOP-3842-180-SWSTOP-3842-180-SW2025-07-24
D7701609743STOP FOR CONICAL DRILL STOP-3842-190-SWSTOP-3842-190-SW2025-07-24
D7701609763STOP FOR CONICAL DRILL STOP-3842-210-SWSTOP-3842-210-SW2025-07-24
D7701609773STOP FOR CONICAL DRILL STOP-3842-220-SWSTOP-3842-220-SW2025-07-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00850016403049ActivSight Imaging Module Clean and Disinfect TrayActiv Surgical, Inc.KCT2026-05-26
00850016403063ActivSight Light Cable Sterilization TrayActiv Surgical, Inc.KCT2026-05-26
00850016403070ActivSight Imaging Module Tray for VHPActiv Surgical, Inc.KCT2026-05-26
00850016403193ActivSight Laparoscope Sterilization TrayActiv Surgical, Inc.KCT2026-05-26
00857387006534Stryker Universal Select Sterilization Tray SystemPARAGON MEDICAL, INC.KCT2026-05-26
00857387006541Stryker Universal Select Sterilization Tray SystemPARAGON MEDICAL, INC.KCT2026-05-26
08800020802767ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802774ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802781ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802798ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802804ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802811ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802828ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802835ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802842ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802859SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802866SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802873SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802880SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802897SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802903SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802910SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802927SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802934SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802996SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803009SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803016SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803023SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803030SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803047SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26