K Number
K032263
Device Name
3I PATIENT-SPECIFIC DENTAL ABUTMENT AND OVERDENTURE BAR
Date Cleared
2004-01-28

(189 days)

Product Code
Regulation Number
872.3640
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 3i Patient-Specific Dental Abutment and Overdenture Bars are intended for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient. It is intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment.
Device Description
The 3i Patient-Specific Dental Abutments and Overdenture Bars are designed to match individual patients.
More Information

No
The summary does not mention AI, ML, image processing, or any related concepts. The device description focuses on patient-specific design, which is likely achieved through traditional CAD/CAM or manufacturing processes, not AI/ML.

No.
The device is an accessory to an endosseous dental implant designed to support a prosthetic device, not to directly treat or diagnose a disease.

No

The device is an accessory to a dental implant, intended to support prosthetic devices. It does not perform any diagnostic function.

No

The device description clearly states it is a "Patient-Specific Dental Abutment and Overdenture Bars," which are physical components intended to be implanted or attached to dental implants. There is no mention of software as the primary or sole component.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the device is an accessory to a dental implant to support a prosthetic device in a patient. This indicates the device is used directly on or within the human body for a therapeutic or restorative purpose.
  • Device Description: The description reinforces that the device is designed to match individual patients, further suggesting a direct application to the patient.
  • Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with bodily specimens.

Therefore, the 3i Patient-Specific Dental Abutment and Overdenture Bars fall under the category of a medical device used for dental restoration, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The 3i Patient-Specific Dental Abutment and Overdenture Bars are intended for use as an accessory to an endosscous dental implant to support a prosthetic device in a partially or edentulous patient. It is intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment.

Product codes

DZE

Device Description

The 3i Patient-Specific Dental Abutments and Overdenture Bars are designed to match individual patients.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

mandible or maxilla

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)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K012911, K991947

Reference Device(s)

K980083, K965077, K962465, K932123, K933462, K933969, K934126, K891613, K871863, K974150, K981858

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

K032263

: 上一篇:

Image /page/0/Picture/3 description: The image is a logo for Implant Innovations, Inc., a Biomet company. The logo features a stylized "3i" in bold, black font. Below the "3i" are the words "IMPLANT INNOVATIONS, INC." and "A BIOMET COMPANY" in a smaller, sans-serif font.

Summary of Safety & Effectiveness

COMPANY:Implant Innovations, Inc.
4555 Riverside Drive
Palm Beach Gardens, FL 33410
CONTACT:Jeannette G. Dailey, RAC
Regulatory Affairs Manager
Telephone: 561-776-6913
Fax: 561-776-6852
E-mail: jdailey@3implant.com
DATE PREPARED:July 21, 2003
NAME OF THE DEVICE:3i Patient-Specific Dental Abutment
3i Patient-Specific Overdenture Bar
CLASSIFICATION:DZE Class III
COMMON NAME:Dental Abutments
PREDICATE DEVICES:The 3i Patient-Specific Dental Abutments and
Overdenture Bars are substantially equivalent to
dental abutments and overdenture bars currently on
the market in overall design and intended use.
Predicate devices include:
K012911
LOCATOR Anchor System
K991947
3i Ceramic Abutment System

3i Ceramic Abutment System

:

1

K980083 3i Orthodontic Abutment Systems

K965077 3i Single Tooth Abutment System

K962465 3i Abutment & Retaining Screw System

K932123 3i Pre-Angled Abutment System

K933462 3i Conical Abutment System

K933969 3i Tapered Abutment System & Components

K934126 3i One and Two Piece Temporary Healing Abutments

K891613 3i Overdenture Attachments

K871863 3i Dental Implant Abutment Systems

K974150 Nobel Biocare, Inc. Procera® Preparable Abutment System

K981858 Atlantis Components, Inc. Atlantis Abutment and Screw

DEVICE DESCRIPTION: The 3i Patient-Specific Dental Abutments and Overdenture Bars are designed to match individual patients.

INDICATIONS FOR USE: The 3i Patient-Specific Dental Abutment and Overdenture Bars are intended for use as an accessory to an endosscous dental implant to support a prosthetic device in a partially or edentulous patient. It is intended for use to support

2

single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment.

SUMMARY OF SAFETY AND EFFECTIVENESS:

Safety and effectiveness problems that have been encountered with similar abutment systems used with endosscous implants may include occasional fractures of the screw; screws becoming loose; or improper mating resulting in inflammation.

3

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 8 2004

Ms. Jeannette G. Dailey Regulatory Affairs Manager Implant Innovations, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410

Re: K032263

Trade/Device Name: 3i Patient-Specific Dental Abutments and Overdenture Bars Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: October 29, 2003 Received: October 30, 2003

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 approvisions of the Act. The general controls provisions of the Act include contrely profit 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 (1 WIT), it they of cash of Federal Regulations, Title 21, Parts 800 to 898. In your device tan be zour wither announcements concerning your device in the Eederal Register.

4

Page 2 - Ms. Dailey

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. 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 (QS) regulation (21 CFR Part 820); and if requirely 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) I mo letter will and in J . 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), n you donte the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

Chus

Chiu Lin, Ph., D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

5

Page 1 of 1

510(k) Number (if known):

Device Name: 3i Patient-Specific Dental Abutments and Overdenture Bars

Indications for Use:

The 3i Patient-Specific Dental Abutment and Overdenture Bars are intended for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient. It is intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suza Runne

(Division Sec. 34) Division of Anesenziology, General Hospital, Infection Control, Dental Devices

510(k) Number: K032263

Prescription Use:
(Per 21 CFR 801.109)

ાર

Over the Counter Use: