UCLA AND CEMENT-ON ABUTMENTS AND ACCESSORIES

K034022 · Diamodent · DZE · Jan 30, 2004 · Dental

Device Facts

• Record ID: K034022
• Device Name: UCLA AND CEMENT-ON ABUTMENTS AND ACCESSORIES
• Applicant: Diamodent
• Product Code: DZE · Dental
• Decision Date: Jan 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The UCLA Abutments and Cement-On Abutments are designed for use with commercially available dental implant systems. These abutments are straight abutments and are NOT angled abutinents. The abutments will scat directly on implants and are sub-structure of prosthesis. Some abutments are used as pattern in dental laboratory to make prosthesis, such as UCLA Plastic Cylinders.

Device Story

DíamoDent UCLA and Cement-On Abutments serve as interface components between endosseous dental implants and final dental prostheses. Devices are straight abutments designed to seat directly onto compatible implant platforms from various manufacturers (Nobel Biocare, Straumann, Dentsply/Friadent, 3i). Some variants, such as UCLA Plastic Cylinders, function as patterns in dental laboratories for prosthesis fabrication. Used by dental professionals in clinical and laboratory settings to restore missing teeth; abutments provide structural support for crowns or bridges. Benefit includes restoration of dental function and aesthetics through standardized mechanical connection to existing implant systems.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Straight dental abutments designed for compatibility with specific Nobel Biocare, Straumann, Dentsply/Friadent, and 3i implant systems. Materials include metal and plastic (UCLA Plastic Cylinders). Mechanical connection via direct seating on implants. Non-sterile.

Indications for Use

Indicated for use as straight abutments for dental implant systems to serve as a sub-structure for dental prostheses. Compatible with specific Nobel Biocare, Straumann, Dentsply/Friadent, and 3i implant systems. Prescription use only.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus features a staff with a serpent entwined around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 0 2004

Ms. Jeff Rassoli President DíamoDent™ 2737 East Regal Park Avenue Anaheim. California 92806

Re: K034022

Trade/Device Name: UCLA and Cement-On Abutments and Accessories Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: December 16, 2003 Received: December 29, 2003

Dear Mr. Rassoli:

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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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 requirences as better as 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), please contact the Office of 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 maj Sound 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,

Oul

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): K034022

UCLA and Cement-On Abutments Device Name:

### Indications for Use:

The UCLA Abutments and Cement-On Abutments are designed for use with commercially available dental implant systems. These abutments are straight abutments and are NOT angled abutinents. The abutments will scat directly on implants and are sub-structure of prosthesis. Some abutments are used as pattern in dental laboratory to make prosthesis, such as UCLA Plastic Cylinders.

All abutments have been designed specifically to be compatible and to be used with each of the following implant systems and sizes (for engineering drawings please refer to Attachment GG),

| IMPLANT COMPANIES | IMPLANT SYSTEMS | IMPLANT SIZE (mm) |
|--------------------|--------------------------------|-----------------------------------------------------|
| Nobel Biocare | NobelPerfect<br>Replace Select | 3.5, 4.3 & 5.0mm<br>3.5, 4.3, 5.0 & 6.0mm |
| Straumann | ITI | 3.5mm Shoulder Diameter<br>Narrow Neck Solid Screw |
| | ITI | 4.8mm Shoulder Diameter<br>Solid Screw |
| | ITI | 6.5mm Shoulder Diameter<br>Wide Neck Solid Screw |
| Dentsply/ Friadent | Frialit-2<br>XIVE | 3.4, 3.8, 4.5, 5.5 & 6.5mm<br>3.4, 3.8, 4.5 & 5.5mm |
| 3i | Osscotite Certain | 4.0, 5.0 & 6.0mm |

Over-The-Counter I Ise Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Suser Ruso

CO34077

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: _

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