ATLANTIS ABUTMENT FOR 3I MICROMINI IMPLANT

K062069 · Atlantis Components, Inc. · NHA · Feb 14, 2007 · Dental

Device Facts

• Record ID: K062069
• Device Name: ATLANTIS ABUTMENT FOR 3I MICROMINI IMPLANT
• Applicant: Atlantis Components, Inc.
• Product Code: NHA · Dental
• Decision Date: Feb 14, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

The devices covered by this submission are abutments which are placed into a dental implant to provide support for a prosthetic reconstruction. The Atlantis Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. Please note: Highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to the limited strength of the implant fixture.

Device Story

Atlantis Abutment is a dental implant accessory; provides support for cement-retained prosthetic restorations. Device consists of abutment and screw; placed over implant shoulder; secured via screw. Used by dental professionals in clinical settings. Compatible with various third-party implant systems (e.g., 3i, Nobel Biocare, BioHorizons, Lifecore, Sterngold, Innova). Highly angled abutments (30°) restricted to anterior region for implants <4mm diameter. Supports early load protocols depending on specific implant system. Benefits patient by enabling prosthetic reconstruction in edentulous sites.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Titanium alloy (ASTM F-136). Endosseous dental implant abutment. Mechanical fixation via screw. Compatible with various specified implant diameters and brands. No software or electronic components.

Indications for Use

Indicated for partially or completely edentulous patients requiring single or multiple tooth prosthetic restorations in the mandible or maxilla. Compatible with specific endosseous dental implants. Contraindicated for highly angled abutments (30 degrees) on implants <4mm diameter in the posterior region due to limited fixture strength.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). 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.)

Predicate Devices

• Atlantis Abutment and Abutment Screw (K981858)
• 3i Osseotite NT Dental Implants (K014235)

Submission Summary (Full Text)

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K062069

Pre-market Notification Page - 00009 - - - - - - - - - - - - - - - -

# VII. SECTION 10 - 510(K) SUMMARY

FEB 1 4 2007

This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR Part 807.92.

# Applicant's Name and Address 1.

....

Atlantis Components Inc. 25 First Street Cambridge, Massachusetts 02141 617-661-9799 Telephone Number: 617-661-9063 Fax Number: Franklin Uyleman Contact Person: Manager of Quality and Regulatory Affairs

### 2. Name of Device

| Trade Name: | Atlantis™ Abutment for 3i MicroMini<br>Implant |
|----------------------|------------------------------------------------------------------------|
| Common Name: | Endosseous dental implant abutment |
| Classification Name: | Endosseous dental implant abutment<br>21 CFR 872.3630 Product code NHA |

# Legally Marketed Device to which Equivalence is claimed (Predicate Device) 3.

| Manufacturer | Device | 510(k)<br>Number |
|-----------------------------|-----------------------------------------|------------------|
| Atlantis Components<br>Inc. | Atlantis Abutment and Abutment<br>Screw | K981858 |
| 3i Implant Innovations | Osseotite NT Dental Implants | K014235 |

# Description of the Device 4.

The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations.

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K062069

Pre-market Page - 00010 --------------------

# Description of the Device (continued) 4.

The Atlantis™ Abutments for 31 MicroMini Implant and abutment screws are made I ne Atlantis - 110 am 2012 (Meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The placed over the mipatible with 3i Ossectite NT® Certain™ Implant 3.25mm and Parallel abulled Implant 3.25mm; Nobel Biocare Mk III 3.3mm, Threaded HL Series 3.3mm, HL Wared Impression 3.25mm, Cylindrical HL Series 3.25mm; BioHorizons Maestro™ 1.5mm; Lifecore Self-tapping 3.75mm, Threaded 3.3mm, Cylinder 3.4mm, Titanium 3.3mm; Sterngold Implamed Hex Screw 3.3mm, 3.75mm, 4.0mm and 5.0mm; Innova Endopore® external 3.5mm and Entegra™ External 3.25mm.

### Intended Use of the Device 5.

The devices covered by this submission are abutments which are placed into a dental implant to provide support for a prosthetic reconstruction. The Atlantis Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. Please note: Highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to the limited strength of the implant fixture.

### Basis for Substantial Equivalence . ୧.

The Atlantis™ Abutments for 3i MicroMini Implants are substantially equivalent in intended use, material, design and performance to the Atlantis Abutments cleared under K981858 and the 3i Osseotite NT Dental Implant System K014235.

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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 (HHS) of the United States. The seal features a stylized eagle with three stripes forming its body, symbolizing service, strength, and skill. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 4 2007

Atlantis Components, Incorporated C/O Ms. Betsy A. Brown Consultant B.A. Brown & Associates 8944 Tamaroa Terrace Skokie, Illinois 60076

Re: K062069

Trade/Device Name: Atlantis™ Abutment for 3i MicroMini Implant Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: February 6, 2007 Received: February 12, 2007

Dear Ms. Brown:

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. Brown

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), 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 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/industry/support/index.html.

Sincerely yours,

Syitte y. Michai Oms

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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K062069

Pre-market Notification Page - 000227

# Indications for Use

510(k) Number (if Known)

Device Name: Atlantis ™ Abutment for 31 MicroMini Implant

Indication for Use:

The Atlantis Abutment is intended for use as an accessory to an endosseous implant to I he i thanks ribution in a partially or completely edentulous patient. It is intended Support a probable in the multiple tooth prosthesis, in the mandible or maxilla. The 10. ase to support bangle and ined to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

The Atlantis Abutment for 3i MicroMini Implant is compatible with the 3i: Osseotite NT® Certain and Parallel Walled Implants both with 3.25mm diameter; Nobel Biocare: NT & Ceram and Farmer Caraner S.3mm, HL Immediate Impression 3.25mm, Cylindrical HL Series 3.25mm; BioHorizons: Maestro™ 3.5mm; Lifecore: Self-tapping 3.75mm, Threaded 3.3mm, Cylinder 3.4mm, Titanium 3.3mm; Sterngold: Implamed Hex Screw 3.3mm, 3.75mm, 4.0mm and 5.0mm, Hex Cylinder 3.3mm; Innova: Endopore® External 3.5mm and Entegra™ External 3.25mm.

Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.

Prescription Use (Part 21 CFR 801 SubpartD)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CQRH, Office of Device Evaluation (ODE) Sugar Conser

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(Division Sign-Om Division of Anasiliestology, General Hospital. Infection Control, Disntal Devices

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