PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS

K051614 · Lifecore Biomedical, Inc. · DZE · Sep 9, 2005 · Dental

Device Facts

• Record ID: K051614
• Device Name: PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS
• Applicant: Lifecore Biomedical, Inc.
• Product Code: DZE · Dental
• Decision Date: Sep 9, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Lifecore Biomedical Dental Implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including: cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The PrimaConnex™ Internal Connection Implant is a threaded implant that is intended for immediate placement and can be restored with a temporary prosthesis in single tooth and multiple tooth applications with good quality bone.

Device Story

System comprises two-stage, root-form tapered and straight-walled threaded dental implants with internal connection anti-rotational feature; includes surgical/restorative instrumentation (drills, taps, depth gauges, drivers). Implants feature Resorbable Blast Media (RBM) roughened surface. Used by clinicians in dental procedures for tooth replacement. Implants placed into mandible or maxilla; restored with temporary or permanent prostheses. Benefits include restoration of dental function and aesthetics for edentulous patients.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Root-form threaded dental implants; titanium construction; Resorbable Blast Media (RBM) surface treatment; internal connection anti-rotational feature; sterilized via gamma irradiation; single-use.

Indications for Use

Indicated for partially or fully edentulous patients requiring single or multiple-unit dental restorations (cement-retained, screw-retained, or overdenture) or fixed bridgework support. Includes immediate placement into extraction sockets and immediate provisionalization (with or without occlusal contact) in good quality bone.

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

• Restore® Self-Tapping Dental Implant System, RD (K924589)
• Restore® Self-Tapping Dental Implant System, WD (K944068)
• Restore® Self-Tapping Dental Implant System, SD (K951111)
• Renova™ Internal Hex Implant System (K032774)
• PrimaSolo™ One-Piece Implant System (K050506)

Submission Summary (Full Text)

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Lifecore Biomedical, Inc. Abbreviated 510(k) Premarket Notification PrimaConnex™ Internal Connection Implant System

K05/614

SEP - 9 2005

## 510(K) SUMMARY AND CERTIFICATION [As required by 21 CFR 807.92(c)]

#### 1. Submitter's Name and Contact Person

| Lifecore Biomedical, Inc. | Rachel Kennedy |
|---------------------------|-------------------------------------|
| 3515 Lyman Blvd | Regulatory Affairs Manager |
| Chaska, MN 55318 | Ph: 952-368-6294; Fax: [phone] |

#### 2. General Information

| Trade Name | Lifecore PrimaConnex™ Internal<br>Connection Implant System |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Endosseous dental implant system |
| Classification Name | Endosseous implant |
| Identification of Predicate Devices | Restore® Self-Tapping Dental<br>Implant System, RD (Lifecore<br>Biomedical, Inc.) (K924589) Restore® Self-Tapping Dental<br>Implant System, WD (Lifecore<br>Biomedical, Inc.) (K944068) Restore® Self-Tapping Dental<br>Implant System, SD (Lifecore<br>Biomedical, Inc.) (K951111) Renova™ Internal Hex Implant<br>System (Lifecore Biomedical, Inc.)<br>(K032774) PrimaSolo™ One-Piece Implant<br>System (Lifecore Biomedical, Inc.)<br>(K050506) |

## 3. Device Description

The Lifecore Biomedical PrimaConnex Internal Connection Implant System consists of two-stage, root-form tapered and straight-walled threaded dental implants and associated abutment systems, which provide the clinician with

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K05/6/4

#### Lifecore Biomedical, Inc. Abbreviated 510(k) Premarket Notification PrimaConnex™ Internal Connection Implant System

screw-retained, cement-retained, and overdenture abutments. The system also includes surgical and restorative instrumentation: twist drills, surgical taps, surgical depth probe, depth gauges, abutment drivers, latch-type drivers, and hand-piece adapters. Lifecore PrimaConnex implants are available with a Resorbable Blast Media (RBM) roughened surface. All implants have an internal connection as an anti-rotational feature for the prosthetics.

#### 4. Intended Use

Lifecore Biomedical Dental Implants are intended for use intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including: cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

The PrimaConnex™ Internal Connection Implant is a threaded implant that is intended for immediate placement and can be restored with a temporary prosthesis in single tooth and multiple tooth applications with good quality bone.

### 5. Substantial Equivalence Comparison

The PrimaConnex Internal Connection Implant System has a substantially equivalent intended use as the identified predicates. All implants are intended for replacing missing teeth and supporting single or multiple-unit restorations in the mandible or maxilla. The Lifecore PrimaConnex Internal Connection Implants are similar in fundamental scientific technology to the predicate devices in that they are all threaded, root form implants constructed of titanium. The subject and predicate devices are similar in size and materials, are sterilized via gamma irradiation and intended for single use only. The PrimaConnex Internal Connection Implant System and the predicates include instruments to assist with the implant procedure. When compared with the predicate devices, no new

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K051614

#### Lifecore Biomedical, Inc. Abbreviated 510(k) Premarket Notification PrimaConnex™ Internal Connection Implant System

questions of safety or effectiveness have been raised for the PrimaConnex Internal Connection Implant System.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized abstract symbol resembling a bird or human figure with three curved lines, enclosed within a circular border. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged around the upper portion of the circle.

SEP - 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Rachel Kennedy Regulatory Affairs Manager Lifecore Biomedical, Incorporated 3515 Lyman Blvd. Chaska, Minnesota 55318-3015

Re: K051614

KUJ1014
Trade/Device Name: PrimaConnex™ Internal Connection Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: DZE Dated: June 16, 2005 Received: June 17, 2005

Dear Ms. Kennedy:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becamer of the device is substantially equivalent (for the relerenced above and have determined te to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate commerce prior to that have been reclassified in accordance with the provisions of Alliendlinens, of to dovrees that in tic Act (Act) that do not require approval of a premarket the rederal I ood, Drug, and Ocements , therefore, market the device, subject to the general approval approvisions of the Act. The general controls provisions of the Act include controls provisions of the ristration, 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 If your device is classified (see above) into sontrols. Existing major regulations affecting g (PMA), it may of subject to back additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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#### Page 2 - Ms. Kennedy

Please be advised that FDA's issuance of a substantial equivalence determination does not r least be advisod that I Dr. o to mination that your device complies with other requirements Incall that I DTT mas mass statutes and regulations administered by other Federal agencies. of the Act of ally I oderal but is requirements, including, but not limited to: registration T ou inust comply with as 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CF R Part 807), caselling systems (QS) regulation (21 CFR Part 820); and if requirements us set form in are quadiation 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) This teller will anow you to began finding of substantial equivalence of your device to a premarket notification. - The Fire 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), if you desire specific and Compliance at [phone]. 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 may overn banel Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Clu

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

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# Indications for Use

## 510(k) Number (if known): K051614

PrimaConnex™ Internal Connection Implant System Device Name:

#### Indications for Use:

Indications for Use:
Lifecore Biomedical Dental Implants are intended for use in partially or fully Lifecore Biomedical Dental Implant System informations on the prouting including,
edentulous mandibles and maxillae, in support of single or intermediate edentulous mandibles and maxiliae, in support of singlo of millions of intermediate abutment support for fixed bridgework.

The PrimaConnex Internal Connection Implant is a threaded internal connection implant. The The PrimaConnex Internal Connection Implant is intended for immediate placement, where PrimaConnex Internal Connection in the local relines of Oral Implantologists
immediate implant placement is defined by the lother into the extraction socket immediate implant placement is delined by the memational only outs of the extraction socket.
(ICOI) as the placement of an implant at the time of tooth extraction socket.

The PrimaConnex Internal Connection Implant is intended for immediation,
Andress of Connection Production in discripcd by the International Congress of The PrimaConnex internal Connection in international on the International Congress of
non-occlusal load. Immediate Provisionalization is discreational of an interim prosthes non-occlusal load. Immediate Provisionalization for the placement of an interim prosthesis with
Oral Implantologists (ICOI) as a clinical protocol for the same clinical visi Oral Implantologists (ICO) as a Cinical proceed for the same clinical visit of implant
or without occlusal contact with the opt of the same clinical visit a tempor or without occlusal contact will the opposing the on be restored with a temporary
placement. The PrimaConnex Internal Connection with and erestored with a temporary placement. The PrimaConnex internal Gonnection maps
prosthesis in single tooth and multiple tooth applications with good quality bone.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of __1_

Susan Ruanor

Division of Anesthesiology, General Hose Infection Control, Dental D

510(k) Number: K051614