(83 days)
Not Found
No
The 510(k) summary describes dental implants and accessories, focusing on their sterilization method. There is no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes.
The device, dental implants and accessories, is indicated to restore a patient's chewing function, which is a therapeutic purpose.
No
The device is a dental implant system and accessories designed for surgical placement and prosthetic attachment to restore chewing function, not for diagnosing medical conditions.
No
The device description clearly states it is a physical dental implant and accessories, which are hardware. The submission is for a change in sterilization method, not a software component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical placement in the jaw to provide a means for prosthetic attachment to restore chewing function. This is a surgical and restorative procedure performed directly on the patient's body.
- Device Description: The description details the surgical implantation of the device into the jawbone and its function as an artificial root structure for prosthetic teeth. This is a physical implant, not a device used to examine specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (blood, urine, tissue, etc.) to provide information about a patient's health status, diagnose a condition, or monitor treatment.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
Implant Innovation, Inc., 3i, Dental Implants and Accessories are indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment to restore a patient's chewing function.
3i Dental Accessories are indicated for use in surgical and restorative applications when placing dental implants.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
Dental implants are surgically inserted into the upper and/or lower jawbone and are left to heal (osseointegrate) with the bone for a period of up to six months. Upon healing and integration with the bone, the cover screw or healing abutment (if used) is removed, impressions are taken, and either a transmucosal abutment (which will later be attached to a custom prosthesis) or an emergence profile (EP) healing abutment is attached to the implant. The soft tissues are allowed to heal around the abutment forming the soft tissues to the contours of the abutment "emergence" profiling. The implant becomes the artificial root structure for a prosthetic tooth or as an abutment structure for bridge work and/or denture retention.
Implant Innovation's dental accessories are available in a wide range of sizes; and are manufactured from various materials.
This premarket notification relates to marketing previously non-sterile 31 dental accessories as sterile for user convenience. The devices are packaged in sterilizationcompatible packaging (heat-sealed nylon pouch) and sterilized by gamma irradiation.
There are no changes to the design, materials, or the Indications for Use for the accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jawbone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The accessories were subjected to multiple exposures of gamma irradiation and analyzed for mechanical strength. An analysis of the data demonstrated there were no significant differences in the materials pre- vs. post-sterilization.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K935544, K952811, K962014, K962465, K965077, K992334, K012911, K013570
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
Image /page/0/Picture/1 description: The image is a logo for 3i Implant Innovations, Inc., a Biomet company. The logo features a large, bold "3" next to a stylized "i" that resembles a rectangular block. Below the numbers, the text "IMPLANT INNOVATIONS, INC." is written in a smaller, sans-serif font, with a line above it. Underneath that, the text "A BIOMET COMPANY" is written in an even smaller font.
COMPANY:
CONTACT:
SEP 1 9 2002
K 022113
Summary of Safety & Effectiveness
Implant Innovations, Inc. 4555 Riverside Drive Palm Beach Gardens, FL 33410
Jeannette G. Dailey, RAC Regulatory Affairs Manager Telephone: 561-776-6913 Fax: 561-776-6852 E-mail: jdailey@3implant.com
DATE PREPARED:
NAME OF THE DEVICE:
CLASSIFICATION:
COMMON NAME:
PREDICATE DEVICES:
June 27, 2002
3i Dental Accessories
DZE Class III
Endosseous Dental Accessories
3i Dental Accessories cleared for marketing via the following premarket notifications:
- K935544 3i Implants ●
- K952811 -- 3i Oral/Maxillofacial . Bone Fixation System
- K962014 3i Single Use, . Disposable Drills, Taps, Burs
- K962465 TIL313 Abutment and . Retaining Screw System
- K965077 -- Single Tooth Abutment . System
- . K992334 - Endosseous Implants and Abutments
- K012911 3i Locater Abutment . System
- K013570 OSSEOTITE® Dental . Implant System
1
DEVICE DESCRIPTION:
Dental implants are surgically inserted into the upper and/or lower jawbone and are left to heal (osseointegrate) with the bone for a period of up to six months. Upon healing and integration with the bone, the cover screw or healing abutment (if used) is removed, impressions are taken, and either a transmucosal abutment (which will later be attached to a custom prosthesis) or an emergence profile (EP) healing abutment is attached to the implant. The soft tissues are allowed to heal around the abutment forming the soft tissues to the contours of the abutment "emergence" profiling. The implant becomes the artificial root structure for a prosthetic tooth or as an abutment structure for bridge work and/or denture retention.
Implant Innovation's dental accessories are available in a wide range of sizes; and are manufactured from various materials.
This premarket notification relates to marketing previously non-sterile 31 dental accessories as sterile for user convenience. The devices are packaged in sterilizationcompatible packaging (heat-sealed nylon pouch) and sterilized by gamma irradiation.
There are no changes to the design, materials, or the Indications for Use for the accessories.
INDICATIONS FOR USE:
Implant Innovation, Inc., 3i, Dental Implants and Accessories are indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment to restore a patient's chewing function.
PERFORMANCE DATA:
The accessories were subjected to multiple exposures of gamma irradiation and analyzed for mechanical strength. An analysis of the data demonstrated there were no significant differences in the materials pre- vs. post-sterilization.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jeanette G. Dailey Regulatory Affairs Manager Implant Innovations. Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410
SEP 1 9 2002
Re: K022113
Trade/Device Name: 3i Dental Implant Accessories Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: III Product Code: DZE Dated: June 27, 2002 Received: June 28, 2002
Dear Ms. Dailey:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
3
Page 2 - Ms. Dailey
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Patricia Cicerityfor
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K022113_
Device Name: 3i Dental Accessories
Indications for Use:
3i Dental Accessories are indicated for use in surgical and restorative applications when placing dental implants.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use:_ (Per 21 CFR 801.109)
OR
Over the Counter Use:_
Susan Russo
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Division Of Anton Dental Devices
510(k) Number: K081113