HEX-LOCK TEMPORARY ABUTMENT

K014050 · Sulzer Dental, Inc. · DZE · Nov 13, 2002 · Dental

Device Facts

• Record ID: K014050
• Device Name: HEX-LOCK TEMPORARY ABUTMENT
• Applicant: Sulzer Dental, Inc.
• Product Code: DZE · Dental
• Decision Date: Nov 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2

Indications for Use

The Hex-Lock Temporary Abutment is designated for use on the internal hexagon implant interface for less than twenty-eight days usage which is placed in the edentulous mandibles or maxillae, for fixation of a final crown. The intended use of the Hex-Lock Temporary Abutment is identical to the intended use of the predicate device, the ProTect abutment from Friadent. The plastic temporary abutment is intended to be used to create an esthetic emergence through the gingiva between implant uncovering and final restoration with screw-retained or cemented restorations. Use of the plastic abutment is not to exceed twenty-eight (28) days. If time between placement of temporary abutment and final restoration needs to exceed twenty-eight (28) days then the use of a titanium abutment, which is indicated for longer-term use, is required. The abutment can be used for either a single tooth or multiple tooth unit provisional restoration and can be modified in height to suit individual needs during the fabrication of the provisional prosthesis.

Device Story

Hex-Lock Temporary Abutment is a dental component for internal hexagon implant systems; used to create esthetic emergence profiles for provisional restorations. Device consists of an internal hex-engaging plastic cylinder with retentive parallel walls and a flared cuff; attaches to implants via a retaining screw with a long shaft. Clinicians modify abutment height to suit individual patient needs during provisional prosthesis fabrication. Used in dental clinics for short-term (≤28 days) screw-retained or cemented restorations. Benefits include esthetic gingival shaping during the healing period between implant uncovering and final restoration placement.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Ultem plastic. Interface: Internal hexagon anti-rotational. Dimensions: 4.5mm, 5.5mm, 6.5mm outer diameters; 3.5mm, 4.5mm, 5.7mm platform diameters. Features: Retentive parallel walls, flared cuff, retaining screw with long shaft (customizable height). Sterile.

Indications for Use

Indicated for patients requiring provisional dental restorations in edentulous mandibles or maxillae. Used for single or multiple tooth units between implant uncovering and final restoration. Contraindicated for use exceeding 28 days; requires transition to titanium abutment for longer durations.

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

• ProTect abutment from Friadent

Submission Summary (Full Text)

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NOV 1 3 2002

K014050

#### 510(K) Summary

Pursuant to 510 (i) of the Federal Food, Drug, and Cosmetic Act, as Amended,

Company Name: . Centerpulse Dental Address: 1900 Aston Avenue, Carlsbad, CA 92008-7308 Telephone Number: 760-929-4300 Registration Number : 2023141 Contact Person: Paula Morgan Date Summary Prepared: November 12, 2002 Classification Name: Abutment Common/Usual Name: Abutment for Dental Implant System Device Trade Name: Hex-Lock Temporary Abutment

The Primary device used for comparison in this summary is ProTect abuttent from Friadent. The ProTect abutment from Friadent is manufactured by FRIADENT GmbH.

#### (The statements of intended use are identical) 1. Intended Use:

The Hex-Lock Temporary Abutment is designated for use on the internal hexagon implant interface for less than twenty-eight days usage which is placed in the edentulous mandibles or maxillae, for fixation of a final crown. The intended use of the Hex-Lock Temporary Abutment is identical to the intended use of the predicate device, the ProTect abutment from Friadent. The plastic temporary abutment is intended to be used to create an esthetic emergence through the gingiva between implant uncovering and final restoration with screw-retained or cemented restorations. Use of the plastic abutment is not to exceed twenty-eight (28) days. If time between placement of temporary abutment and final restoration needs to exceed twenty-eight (28) days then the use of a titanium abutment, which is indicated for longer-term use, is required.

. The abutment can be used for either a single tooth or multiple tooth unit provisional restoration and can be modified in height to suit individual needs during the fabrication of the provisional prosthesis.

#### 2. Description:

The Hex-Lock Temporary Abutment is available in 4.5mm, 5.5mm, and 6.5mm outer diameter lengths for the internal hexagon interface. The abutment/implant platform diameter is 3.5mm, 4.5mm, and 5.7mm for the internal hexagon interface. All the abutments exhibit the internal hexagon interface.

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### 3. Technological Characteristics:

The Hex-Lock Temporary Abutment is a new abutment design that is being submitted to interact with an internal hexagon dental implant system. The abutment features an internal hex engaging plastic cylinder with retentive parallel walls and a flared cuff used for short term restorations less than twenty-eight (28) days. This abutment will attach directly to the implant with a retaining screw with a long shaft that protrudes from the top of the abutment to facilitate the fabrication of the provisional prosthesis. Both screws allow for length reduction for custom height restorations. The abutment will exhibit the internal hex engaging feature. The abutment/implant interface remains unchanged,

### 4. Comparison Analysis:

The overall design of the Hex-Lock Temporary Abutments are identical to the predicate abutment. See Table 1 below for a comparison of the Hex-Lock Temporary Abutment and the predicate implant.

| Feature | Flex-Lock Temporary<br>Abutment | Predicate Abutment |
|----------------------------|----------------------------------|---------------------------------------------------|
| Abutment Body Geometry | Straight Retentive Wall | Straight Retentive Wall |
| Abutment Diameters | 4.5mm, 5.5mm, 6.5mm | 3.4mm, 3.8mm, 4.5mm,<br>5.5mm, & 6.5mm |
| Abutment/Implant Diameter | 3.5mm, 4.5mm, 5.7mm | 3.4mm, 3.8mm, 4.5mm,<br>5.5mm, & 6.5mm |
| Abutment Body Material | Ultem | PEEK |
| Implant/Abutment Interface | Hex anti-rotational interface | Hex anti-rotational<br>interface |
| Manufacturing Site | Carlsbad, CA | Mannheim, Germany |
| Packaging | Tyvek® tray in chipboard<br>box. | Blister pack combined w/<br>cardboard outer wrap. |
| Sterile | Yes | No |

Table: 1 Summary of Comparison

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three heads.

#### Public Health Service

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 1 3 2002

Ms. Paula Morgan Manager, Regulatory Affairs Sulzer Dental, Incorporated 1900 Aston Avenue Carlsbad, California 92008-7308

Re: K014050

Trade/Device Name: Hex-Lock Temporary Abutment Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: August 23, 2002 Received: August 26, 2002

Dear Ms. Morgan:

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.

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Page 2 - Ms. Morgan

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 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 [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" (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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Palermo Ciconte //fer

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

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510(K) Number (if known): K014050

Device Name: Hex-Lock Temporary Abutment

Indications for Use:

The plastic temporary abutment can be used to create esthetic, screw-retained or cemented provisional restorations at second stage uncovering. Once the restoration has been applied to the temporary abutment, it can be used to develop a more esthetic emergence profile. Temporary abutment is not to be used as a permanent abutment. Not to exceed 28-days of placement.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | <span style="text-decoration: overline;">✓</span> |
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OR

| Over-The-Counter-Use (Optional Format 1-2-96) | <span style="text-decoration: overline;"></span> |
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(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K014050