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Implant Innovations, Inc.

United StatesFDA applicant, unverified

Devices
51
FDA recalls
9

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Implant Innovations, Inc. makes

Implant Innovations, Inc. manufactures dental implant accessories, including abutment and retaining screw systems, temporary cylinders, and threaded implants with hydroxyapatite coatings. Their portfolio includes standard threaded and self-tapping dental implants, minipants, and modifications to existing implant systems like Osseotite NT. The company also produces calcium sulfate bone cement and endosseous implants with tin coatings, as well as intraocular lens (IOL) implants.

The company’s devices are classified under FDA regulations as Class I and Class II, with submissions recorded in the FDA’s 510(k) registry. Products are listed under the U.S. jurisdiction, adhering to applicable medical device regulations.

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

Catalogue51

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FDA recalls9

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

FDA recall records list 9 recalls initiated by Implant Innovations, Inc., the earliest on 2003-01-28 and the most recent on 2004-10-04. By recorded status: 9 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination and 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.

  • 2004

    • 4 Oct 2004 Z-0029-05 Unclassified (pre-2012) Terminated The nylon bag holding the product was not completely sealed before sterilization. Patients could be infected if the abutment is implanted. Distribution: Distributed to 34 direct accounts throughout the United States and four international accounts in Europe, Asia, South…
      Full distribution text Distributed to 34 direct accounts throughout the United States and four international accounts in Europe, Asia, South America and the middle East.
      Submission number: K934126

  • 2003

    • 2 Dec 2003 Z-0383-04 Unclassified (pre-2012) Terminated The tray lid seals may be open thereby compromising the sterility barriers for the recalled lots. Distribution: Product was distributed to 45 Dentist/Surgeons nationwide in the US and also to 13 international Distributors in Canada,…
      Full distribution text Product was distributed to 45 Dentist/Surgeons nationwide in the US and also to 13 international Distributors in Canada, Sweden, Germany, Colombia, Spain, Switzerland, Australia, Japan, Austria, France, Poland, England and Greece.
    • 2 Dec 2003 Z-0384-04 Unclassified (pre-2012) Terminated The tray lid seals may be open thereby compromising the sterility barriers for the recalled lots. Distribution: Product was distributed to 45 Dentist/Surgeons nationwide in the US and also to 13 international Distributors in Canada,…
      Full distribution text Product was distributed to 45 Dentist/Surgeons nationwide in the US and also to 13 international Distributors in Canada, Sweden, Germany, Colombia, Spain, Switzerland, Australia, Japan, Austria, France, Poland, England and Greece.
    • 2 Dec 2003 Z-0385-04 Unclassified (pre-2012) Terminated The tray lid seals may be open thereby compromising the sterility barriers for the recalled lots. Distribution: Product was distributed to 45 Dentist/Surgeons nationwide in the US and also to 13 international Distributors in Canada,…
      Full distribution text Product was distributed to 45 Dentist/Surgeons nationwide in the US and also to 13 international Distributors in Canada, Sweden, Germany, Colombia, Spain, Switzerland, Australia, Japan, Austria, France, Poland, England and Greece.
    • 2 Dec 2003 Z-0386-04 Unclassified (pre-2012) Terminated The tray lid seals may be open thereby compromising the sterility barriers for the recalled lots. Distribution: Product was distributed to 45 Dentist/Surgeons nationwide in the US and also to 13 international Distributors in Canada,…
      Full distribution text Product was distributed to 45 Dentist/Surgeons nationwide in the US and also to 13 international Distributors in Canada, Sweden, Germany, Colombia, Spain, Switzerland, Australia, Japan, Austria, France, Poland, England and Greece.
    • 2 Dec 2003 Z-0387-04 Unclassified (pre-2012) Terminated The tray lid seals may be open thereby compromising the sterility barriers for the recalled lots. Distribution: Product was distributed to 45 Dentist/Surgeons nationwide in the US and also to 13 international Distributors in Canada,…
      Full distribution text Product was distributed to 45 Dentist/Surgeons nationwide in the US and also to 13 international Distributors in Canada, Sweden, Germany, Colombia, Spain, Switzerland, Australia, Japan, Austria, France, Poland, England and Greece.
    • 9 May 2003 Z-0923-03 Unclassified (pre-2012) Terminated Some 8mm OsseoFix drills included in the kit may be incorrectly laser marked as 4mm OsseoFix drills. Distribution: Nationwide & France, Japan, Spain, Germany, Korea, Australia, Argentina, Denmark, Chile, England, Brazil.
    • 9 May 2003 Z-0924-03 Unclassified (pre-2012) Terminated Some 8mm OsseoFix drills may be incorrectly laser marked as 4mm OsseoFix drills. Distribution: Nationwide & France, Japan, Spain, Germany, Korea, Australia, Argentina, Denmark, Chile, England, Brazil.
    • 28 Jan 2003 Z-0665-03 Unclassified (pre-2012) Terminated Sterile Endosseous implants may be packaged in mislabeled packaging with the incorrect size. Distribution: Product was distributed to four international distributor accounts only in Brasil, Korea, Taiwan and Chile. Submission number: K950204

Frequently asked questions

How many devices does Implant Innovations, Inc. have in the registry?

The registry currently lists 51 devices for Implant Innovations, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Implant Innovations, Inc.'s devices?

Among its 50 most recently registered devices, Implant Innovations, Inc. has devices listed in FDA 510(k) (50 devices).

What risk classes do Implant Innovations, Inc.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Implant Innovations, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Implant Innovations, Inc.?

FDA recall records list 9 recalls initiated by Implant Innovations, Inc., the most recent initiated on 2004-10-04. 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 Implant Innovations, Inc. in the registry?

The most recently registered devices listed for Implant Innovations, Inc. include 3I DENTAL IMPLANT ACCESSORIES, MODIFICATION TO OSSEOTITE NT CERTAIN IMPLANTS, 3I CALCIUM SULFATE BONE CEMENT and PROVIDE TEMPORARY CYLINDER.

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