Skip to content

Imtec Corp.

United StatesFDA applicant, unverified

Devices
28
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Imtec Corp. makes

Imtec Corp. manufactures dental and surgical products including titanium mesh, bone collector systems, bone tacs, and biobarrier membranes. Their portfolio also features various dental implants such as the Endure, Saber Tech, and MDI MII systems, along with associated components like Hexlock screws and Secure Soft materials.

These devices are categorized as Class I and Class II medical devices. The company is based in the United States, and its products are listed within the FDA 510(k) regulatory registry.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue28

Newest first, rows 1-28 of 28

Search and filter all 28 devices
Skip device list

  • Imtec/Titanium Mesh Ref K970841

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Endure Implant, Model 5108, 5111, 5113, 5114 Ref K072660

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Secure Soft Ref K021437

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Hexlock/Hexlock Screw Ref K932168

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Imtec Bone Collector System Ref K973248

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Biocellect -Perio Ref K020396

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Saber Tech Implants System Ref K024044

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Imtec Biobarrier Ref K950306

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Mdi Mii One-Piece Implant, 2.9mm Ref K081653

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Imtec Bone Tac Ref K973180

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Endure Implant, Model 3508, 3511, 3514, 4308, 4311, 4314 Ref K030243

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Imtec/Biobarrier Membrane Ref K974752

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Hexlock Ref K912262

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Mdi Ortho Ref K042289

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Laparoscopy Sets, Needle Holders, Blunt Shears Ref K923259

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Imtec Sendax Mdi And Mdi Plus Endosseous Implant, Models Ob-Xx, Sh-Xx, Mob-22, Msh-Xx Ref K031106

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Laparoscopy Sets, Needle Holders, Blunt Curved Ref K923260

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Imtec Sendax Mdi ORTHO6 And ORTHO8 Ref K023067

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Hexlock Screw Ref K920909

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Endure Implant, Models 3508, 4308, 3520, 4320 Ref K043226

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Lexatite Quick Acrylic Ref K033432

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Iluma Orthocat/Dentalcat Ref K053046

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Secure Reline/Pickup Material Ref K021586

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Imtec Biobarrier Membrane Ref K972240

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Iluma Vision Ref K081347

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Biocellect Ref K010775

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Modification To Imtec Sendax Mdi Ref K990983

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Imtec Biopin Ref K982951

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-28 of 28

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 1 recall initiated by Imtec Corp., initiated on 2009-07-07. By recorded status: 1 terminated. The reasons filed fall into these groups: packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2009

    • 7 Jul 2009 Z-1997-2009 Unclassified (pre-2012) Terminated Size printed on product packaging does not match size of enclosed product. Distribution: Worldwide -- US, Azerbaijan, Guatemala, Turkey, and Germany. Submission number: K081653

Frequently asked questions

How many devices does Imtec Corp. have in the registry?

The registry currently lists 28 devices for Imtec Corp.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Imtec Corp.'s devices?

Among its 28 most recently registered devices, Imtec Corp. has devices listed in FDA 510(k) (28 devices).

What risk classes do Imtec Corp.'s devices fall under?

Among its 28 most recently registered devices, the classes recorded for Imtec Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Imtec Corp.?

FDA recall records list 1 recall initiated by Imtec Corp., the most recent initiated on 7 Jul 2009. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Imtec Corp. in the registry?

The most recently registered devices listed for Imtec Corp. include IMTEC/TITANIUM MESH, ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114, SECURE SOFT and HEXLOCK/HEXLOCK SCREW.

Generated automatically from registry data and not verified by a human reviewer.