LIFECORE O-RING ABUTMENT;LIFECORE DALLA BONA ABUTMENT

K970776 · Lifecore Biomedical, Inc. · DZE · May 27, 1997 · Dental

Device Facts

• Record ID: K970776
• Device Name: LIFECORE O-RING ABUTMENT;LIFECORE DALLA BONA ABUTMENT
• Applicant: Lifecore Biomedical, Inc.
• Product Code: DZE · Dental
• Decision Date: May 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Implant systems are for use in edentulous mandibles and maxillae as a support or attachment for prosthetic restoration.

Device Story

Lifecore O-Ring and Dalla Bona Abutments serve as attachment components for endosseous dental implants. Designed for use in upper or lower jaws, these abutments provide retention for overdentures. The device is installed by a dental professional during prosthetic restoration procedures. It functions as a mechanical interface between the implanted endosseous fixture and the removable prosthetic appliance, facilitating stability and retention for the patient's dental restoration.

Clinical Evidence

No clinical data provided; substantial equivalence is based on identical technological characteristics and materials compared to predicate devices.

Technological Characteristics

Titanium abutments for endosseous dental implants. Mechanical attachment design (O-ring and Dalla Bona styles). Identical in material, manufacturing, and structure to predicate devices.

Indications for Use

Indicated for partially or fully edentulous mandibles or maxillae for support of fixed cemented restorations, fixed detachable screw-retained prosthetics, overdenture retention (ball, o-ring, dalla bona, or hader bar), terminal or intermediate abutment support for fixed bridgework, and free-standing restorations.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Lifecore Overdenture Abutments Systems (K921764)
• Lifecore Overdenture Abutments Systems (K924190)

Submission Summary (Full Text)

{0}

MAY 27 1997
K970776 LIFECORE
BIOMEDICAL

# 510(k) Summary

## VII Summary of Safety and Effectiveness
As required by 807.92(c).

1. This summary of Safety and Effectiveness is being submitted by:
Lifecore Biomedical, Inc.
3515 Lyman Blvd
Chaska, MN 55318
[phone]
Fax: [phone]

Contact Person: Donna Bahls
Regulatory Affairs Manager,
Oral Restorative Division

Date: December 13, 1996

2. Trade Name: Lifecore O-Ring Abutment and Lifecore Dalla Bona Abutment
Common Name: Overdenture Abutment
Classification Name: Attachment accessory for Class III Endosseous Implants
(per 21 CFR 872.3165).

3. Equivalent Device: The device is substantially equivalent to the commercially marketed
products known as Lifecore Overdenture Abutments Systems (K921764, K924190).

4. Device Description: The abutment is designed for use with an endosseous implant which is
implanted in the lower or upper jaw. The abutment is used as an attachment solution to
overdentures.

5. Intended Use: Implant systems are for use in edentulous mandibles and maxillae as a
support or attachment for prosthetic restoration.

6. The technological characteristics of the modified versions of the o-ring and dalla bona
abutments and the earlier versions are identical. The titanium used in both devices is the
same. Manufacturing processes are also the same as is general shape and structure.
Therefore, no new types of technology and no new technological questions are involved.

3515 LYMAN BOULEVARD • CHASKA, MINNESOTA • 55318-3051 • USA
612•368-4300 FAX: 612•368-3411
8
PRINTED ON RECYCLED PAPER WITH
18% POST-CONSUMER PRINT

{1}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

MAY 27 1997

Ms. Donna Bahls
Regulatory Affairs Manager
Oral Restorative Division
Lifecore Biomedical, Incorporated
3515 Lyman Boulevard
Chaska, Minnesota 55318-3051 USA

Re: K970776
Trade Name: Lifecore O-Ring Abutment; Lifecore Dalla
Bona Abutment
Regulatory Class: III
Product Code: DZE
Dated: February 27, 1997
Received: March 4, 1997

Dear Ms. Bahls:

We have reviewed your Section 510(k) notification of intent to
market the device referenced above and we have determined the
device is substantially equivalent (for the indications for
use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A
substantially equivalent determination assumes compliance with
the Good Manufacturing Practice for Medical Devices: General
(GMP) regulation (21 CFR Part 820) and that, through periodic
GMP inspections, the Food and Drug Administration (FDA) will
verify such assumptions. Failure to comply with the GMP
regulation may result in regulatory action. In addition, FDA
may publish further announcements concerning your device in
the Federal Register. Please note: this response to your
premarket notification submission does not affect any
obligation you might have under sections 531 through 542 of

{2}

Page 2 - Ms. Bahls

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director
Division of Dental, Infection Control, and General Hospital Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

{3}

6

# Indications for Use:

The Lifecore Sustain and Restore Dental Implant Systems are intended for use in either partially or fully edentulous mandibles or maxillae in the following areas:

- Support of fixed (cemented) restorations utilizing multiple abutments;
- Support of fixed detachable (screw retained) prosthetics utilizing multiple abutments;
- Overdenture retention by means of a ball overdenture attachment, o-ring attachment, dalla bona or hader bar;
- Terminal or intermediate abutment support for fixed bridgework;
- Free standing restorations without involvement of adjacent dentition.


(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number 10970776