CAMLOG DENTAL IMPLANT ABUTMENTS, HEALING CAPS, AND ACCESSORIES

K051636 · Altatec GmbH · NHA · Feb 17, 2006 · Dental

Device Facts

• Record ID: K051636
• Device Name: CAMLOG DENTAL IMPLANT ABUTMENTS, HEALING CAPS, AND ACCESSORIES
• Applicant: Altatec GmbH
• Product Code: NHA · Dental
• Decision Date: Feb 17, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CAMLOG implants are used to support dental prostheses in the upper and lower jaws. They may be used for functional and aesthetic oral restoration of partially edentulous and edentulous jaws using crowns, bridges, partial or complete prostheses, which are connected to CAMLOG implants using suitable components. CAMLOG Ball Abutments support implant retained mucosa supported overdentures. CAMLOG Bar Abutments (including bases) support custom milled or prefabricated bars for overdentures. CAMLOG Healing Caps (Cylindrical, Wide Body, Bottleneck, and for Bar Abutment) displace the gingiva from the space above the CAMLOG implant or bar abutment during the CAMLOG implant healing time and serve for proper gingiva shaping.

Device Story

CAMLOG dental implant components include healing caps, ball abutments, bar abutments, bases, and gold copings. Healing caps displace gingiva during healing; ball abutments support mucosa-supported overdentures; bar abutments support bars for overdentures. Components are used by dentists/prosthodontists in clinical settings. Bases and gold copings are processed by dental laboratories via soldering, laser-welding, or casting to adapt to specific patient anatomy. Components connect to CAMLOG implants in maxilla or mandible. Ball abutment use requires implant axis angle ≤10°. Devices provide structural support for dental prostheses, restoring oral function and aesthetics.

Clinical Evidence

Bench testing only. No clinical data provided. Design and manufacturing verified against FDA Class II Special Controls Guidance Document for Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments (May 12, 2004).

Technological Characteristics

Materials: TiAl6V4 (Titanium alloy), Titanium Grade 4, noble metal alloys (Elitor, Elunor WP, Cerunor), POM (burn-out sleeves), stainless steel. Components include healing caps (cylindrical, wide body, bottleneck), ball abutments, bar abutments, bases, and gold copings. Sterilization: Gamma irradiation (healing caps) and steam sterilization. Connectivity: None (mechanical).

Indications for Use

Indicated for patients requiring functional and aesthetic oral restoration of partially or fully edentulous jaws. Used to support dental prostheses (crowns, bridges, partial or complete dentures) via CAMLOG implants. Ball abutments support implant-retained mucosa-supported overdentures; bar abutments support custom or prefabricated bars for overdentures. Healing caps are used for gingival shaping during the healing phase.

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

• Straumann Dental Implant System - Healing caps (Unknown)
• Replace Select Implant System - Healing abutments (Unknown)
• Straumann Dental Implant System - Retentive anchors (Unknown)
• Replace Select Implant System - O-Ring abutments (Unknown)
• Straumann Dental Implant System - Screw retained abutments (Unknown)
• Replace Select Implant System - PME-Abutments (Unknown)
• RN synOcta Gold Cap Item No. 048.632 (Unknown)
• PME Coping, Gold Item No. 2149 (Unknown)

Submission Summary (Full Text)

{0}------------------------------------------------

FEB 17 2006

Ko51636

# 510(k) SUMMARY CAMLOG Endosseous Dental Implant Abutments, Healing Caps and Accessories

This summary of 510(k) safety and effectiveness information is being submitted in 1115 Sunnally of STS (1) Janoty at s of SMDA 1990 and 21 CFR, Section 807.92.

Date Prepared: February 17, 2006

# A. Submitter's Name, Address, Phone and Fax Number

# 1. Manufacturer of the subject devices

Altatec GmbH Maybachstrabe 5 Wirnsheim, Germany 71299 Phone [phone]-503 Fax [phone]-563 Registration No. 9613866

## 2. Name of Contact Person

Tina Steffanie-Oak Senior Regulatory Affairs Specialist Camlog U.S.A. 520 South Rock Blvd. Reno, NV 89502 Phone [phone] Facsimile 631-843-5557 Registration No. 3004575151

## 8. Device Name, Common Name

## 1. Device Names

CAMLOG Dental Implant Abutments, Healing Caps, and Accessories

#### 2. Common/Usual Name

Endosseous Dental Implant Abutments, Healing Caps and Accessories

## 3. Classification Name:

Class II Device, Endosseous Dental Implant Abutments, NHA

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# C. Predicate Devices:

Healing Caps:

| Device Name | Manufacturer | 510(k) No. |
|------------------------------------------------------|-----------------------|------------|
| Straumann Dental Implant System<br>- Healing caps | Institut Straumann AG | Unknown |
| Replace Select Implant System<br>- Healing abutments | Nobel Biocare | Unknown |

# Ball Abutments:

| Device Name | Manufacturer | 510(k) No. |
|--------------------------------------------------------|-----------------------|------------|
| Straumann Dental Implant System<br>- Retentive anchors | Institut Straumann AG | Unknown |
| Replace Select Implant System<br>- O-Ring abutments | Nobel Biocare | Unknown |

# Bar Abutments:

| Device Name | Manufacturer | 510(k) No. |
|---------------------------------------------------------------|-----------------------|------------|
| Straumann Dental Implant System<br>- Screw retained abutments | Institut Straumann AG | Unknown |
| Replace Select Implant System<br>- PME-Abutments | Nobel Biocare | Unknown |

# Healing Caps for Bar Abutments:

| Company Company of Children Company<br>Device Name | Manufacturer | 510(k) No. |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|------------|
| COLOR COLLECT COLLEGE E CONNER OF CONNECT COLLEGION OF CONNUMBER COLLEGION OF CONNUMBER OF CONNUMBER OF CONNUMBER OF CONNOME OF CONNOME OF CONNOME OF CONNOME OF CONNOME OF CO<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Callery Co. Boxes an<br>Healing<br>2700<br>m No | Kingare<br>Acres of All All | Unknown |

# Bases and Gold Coping for Bar Abutments:

| Device Name | Manufacturer | 510(k) No. |
|--------------------------------------|-----------------------|------------|
| RN synOcta Gold Cap Item No. 048.632 | Institut Straumann AG | Unknown |
| PME Coping, Gold Item No. 2149 | Nobel Biocare | Unknown |

# D. Description of the Devices

# 1. Device Description

The following list of products are used solely in combination with the implantation of CAMLOG dental implants.

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# Healing Caps - Cylindrical, Wide Body, Bottleneck

Healing caps of specific diameters and shapes are fixated on the implants to disclace the gingiva from the space above the implant during the implant healing time and serve for proper gingiva shaping. They are offered in three different shapes; cylindrical, wide body and bottleneck and are available in diameters of 3.3, 3.8, 4.3, 5.0 and 6.0mm. The cylindrical and wide body healing caps are available in Gingival Heights (GH) of 2.0, 4.0 and 6.0mm. The bottleneck healing cap is available in two Gingival Heights of 4.0 and 6.0mm.

## Healing Caps for Bar Abutment

This healing cap is connected to the bar abutment and is intended to form the gingival shape similar to the healing caps described above. There are two healing caps for use with the bar abutment, which are made of TiAl6V4. Both have an overall height of 3.65mm, but differ in the base diameter of 4.30 or 6.0mm maasured at the outer tube wall.

## Ball Abutment

Ball abutments are used for implant-retained mucosa-supported restorations, such as dentures. The ball abutment technique is used on Camlog implants in the maxilla or mandible. When using the ball abutment, the angle of the implant axes must not be more than 10°. Ball abutments with the following diameters are available: 3.3, 3.8, 4.3 and 5.0mm. The male part for each diameter is available in protrusion heights of 1.5, 3.0 and 4.5mm. There are a total of 12 different size ball abutment systems being offered by Altatec.

#### Bar Abutment

Camlog bar abutments serve to support custom-milled or prefabricated bars to which an overdenture is attached. The bar abutment technique is used on Camlog implants in the maxilla or mandible. The bar abutments are available in various diameters, which include 3.3. 3.8, 4.3, 5,0 and 6.0mm. Each diameter is available in three different protrusion heights of 0.5, 2.0 and 4.0mm. There are a total of 15 different sizes that will be offered for sale.

### Bases for Bar Abutment (Solderable, Laser-Weided, Cementable)

The purpose of each specific base is to have a base adapted in geometry and materials selection to each of the following processes: soldering, laser-welding, and cementing. The selection of a specific processing method is made by the dental laboratory.

# Gold Coping for Bar Abutment Cast-on

The purpose of the specific gold coping is to have a base adapted in geometry and materials selection to the casting process. The selection of a specific processing method is made by the dental laboratory. We are offering two gold copings for bar abutment cast-on of different sizes, which are compatible to the bar abutments of 3.3, 3.8 and 4.3mm diameter or of 5.0 and 6.0mm diameter.

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# Prosthetic Screw for Bar Abutment

There are two prosthetic screws for bar abutment, both 5.5 mm long. They vary by diameter (2.10 and 2.50mm) of the cylindrical shank and by the size of the thread (M1.6 and M2). The screws serve to fix the bases or the gold coping to the bar abutment.

# Screw for Bar Abutment

There are two screws for bar abutment. Both screws are 20.5 mm long. They vary by diameter (2.1 and 2.5mm) of the cylindrical shank and by the size of their threads (M1.6 and M2). The thread serves to guide and stabilize the impression post through the hollow core of which the screw is directed.

## 2. Design

The CAMLOG Dental Implant Abutments, Healing Caps, and Accessories have been designed, manufactured and tested in compliance with FDA's Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, May 12, 2004.

#### 3. Materials

- a. The Healing Caps are made of TiAl6V4.
- The Female part of the Ball Abutment is made of titanium grade 4, and ﻗ noble metal alloy Elitor®. The Male part is made of TiAlBV4.
- The Bar Abutments are made of TiAI6V4. ü
- d. The Solderable Bases are made of noble metal alloy Elunor® WP. Cementable Bases is made of TiAl6V4 and the Laser-Weldable Bases are made of Titanium Grade 4
- e. The Gold Copings are made of the castable noble metal alloy Cerunor®. The burn-out sleeves are made of POM.
- The Prosthetic Screws for Bar Abutment are made of TiAl6V4. ﻨﺖ
- g. The Screws for Bar Abutment are made of stainless steel.

#### 4. Intended Use

CAMLOG implants are used to support dental prostheses in the upper and lower laws.

They may be used for functional and aesthetic oral restoration of partially edentulous and edentulous jaws using crowns, bridges, partial or complete prostheses, which are connected to CAMLOG implants using suitable components.

CAMLOG Ball Abutments support implant retained mucosa supported overdentures.

CAMLOG Bar Abutments (including bases) support custom milled or prefabricated bars for overdentures.

{4}------------------------------------------------

| Diameters | 4.3 and 8 mm | unknown |
|---------------------------------------|-----------------------------------------------|------------------------------------------------------------------------------------|
| Height | 3.65 mm | unknown |
| Material | Titanium Alloy | Titanium Alloy |
| Reprocessing Method | Steam Sterilization | Disinfection |
| Compatibility with Dental<br>Implants | Compatible only with CAMLOG<br>Implant System | Compatible only with Replace<br>Select Dental Implant System<br>from Nobel Biocare |

# Comparison Table for Healing Caps

| Item | Subject Device<br>Healing Cap | Predicate Device<br>Healing Cap | Predicate Device<br>Healing Cap |
|----------------|-------------------------------|---------------------------------|---------------------------------|
| Item Number(s) | J2010.3340 | 048..033 | 61019 |
| | J2010.3360 | 048.034 | 61020 |
| | J2010.3840 | 048.037 | 61021 |
| | J2010.3860 | | 61022 |
| | J2010.4340 | | 61023 |
| | J2010.4380 | | 61024 |
| | J2010.5040 | | 61025 |
| | J2010.5080 | | 61026 |
| | J2010.6040 | | 61027 |
| | J2010.6060 | | 61028 |
| | J2013.3320 | | 61029 |
| | J2013.3340 | | 61030 |
| | J2013.3360 | | 61031 |
| | J2013.3820 | | 61033 |
| | J2013.3840 | | 61034 |
| | J2013.3860 | | 61035 |
| | J2013.4320 | | 61036 |
| | J2013.4340 | | 61037 |
| | J2013.4360 | | 61038 |
| | J2013.5020 | | 61039 |
| | J2013.5040 | | 61040 |
| | J2013.5060 | | 61041 |
| | J2013.6020 | | 61042 |
| | J2013.6040 | | 61043 |
| | J2013.6080 | | 61044 |
| | J2015.3320 | | 61045 |
| | J2015.3340 | | |
| | J2015.3380 | | |
| | J2015.3820 | | |
| | J2015.3840 | | |
| | J2015.3860 | | |
| | J2015.4320 | | |
| | J2015.4340 | | |
| | J2015.4380 | | |
| | J2015.5020 | | |
| | J2015.5040 | | |
| | J2015.5060 | | |
| | J2015.6020 | | |

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| Manufacturer | Altatec<br>J2015.6040<br>J2015.6060 | Institut Straumann<br>AG | Nobel Biocare |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|---------------------------------------------------------------------------------------|
| 510K# | Part of this submission | Unknown | Unknown |
| Intended Use | CAMLOG Healing Caps<br>(Cylindrical, Wide Body,<br>Bottleneck) displace the<br>gingiva from the space<br>above the CAMLOG<br>implant or bar abutment<br>during the CAMLOG<br>implant healing time and<br>serve for proper gingiva<br>shaping. | Same | Same |
| Diameters | 3.3, 3.8, 4.3, 5 and 6 mm | 3.3, 4.1 and 4.8 | 3.5, 4.3, 5.0 and 6.0 mm |
| Gingival Heights | 2, 4 and 6 mm | 2, 3 and 4.5 mm | 3, 5 and 7 mm |
| Shapes | Cylindrical, Wide Body,<br>and Bottleneck | Cylindric | Cylindric |
| Material | Titanium Alloy | Titanium | Titanium Alloy |
| Sterilization<br>Method | Gamma Irradiation | Unknown | Unknown |
| Compatibility<br>with Dental<br>Implants | Compatible only with<br>CAMLOG Implant System | Compatible only with<br>Straumann Implant<br>System | Compatible only with<br>Replace Select Dental<br>Implant System from<br>Nobel Biocare |

# Companison table for Bases and Gold Coping used with Bar Abutments

| | Subject Device | Predicate<br>Device | Predicate Device |
|----------------|----------------------------------------------------------------------------------------------------------------|---------------------|------------------|
| Item | Base | | |
| Item Number(s) | Base for bar abutment,<br>Solderable<br>J2258.4300<br>J2258.6000 | | |
| | Titanium cementable base,<br>passive-fit<br>J2260.3300<br>J2260.3800<br>J2260.4300<br>J2260.5000<br>J2260.6000 | | |
| | Base for bar abutment, laser-<br>weldable<br>J2262.4300<br>J2262.6000 | | |

{6}------------------------------------------------

| | Gold coping for bar abutment,<br>cast-on with burn-out sleeve<br>J2263.4300<br>J2263.6000 | RN synOcta<br>gold cap<br>048.632 | PME Coping, Gold<br>2149 |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Manufacturer | Altatec | Institut<br>Straumann<br>AG | Nobel Biocare |
| 510K# | Part of this submission | Unknown | Unknown |
| Intended Use | CAMLOG Bar Abutments<br>(including bases) support custor<br>milled or prefabricated bars for<br>overdentures. | Same | Same |
| Diameters | 3.3, 3.8, 4.3, 5.0 and 6.0 mm | 3.3, 4.1 and<br>4.8 | 3.5, 4.3 and 5.0 mm |
| Material | Base for bar abutment,<br>Solderable:<br>Elunor®: Au 70.0%, Pt 8.50%,<br>Ag 13.40%, Cu 7.50,<br>Zn 0.50%, Ir 0.10%<br>Titanium cementable base,<br>passive-fit:<br>Titanium Alloy<br>Base for bar abutment, laser-<br>weldable:<br>Titanium Alloy<br>Gold coping for bar abutment,<br>cast-on (Cerunor®) with bum-out<br>sleeve:<br>Cerunor®: Au 60%, Pt 19%,<br>Pd 20%, Ir 1% | RN synOcta<br>gold cap<br>048.632:<br>Ceramicor: Au<br>60%, Pt 19%,<br>Pd 20%, Ir 1% | Unknown |
| Reprocessing<br>Method | Steam Sterilization | unknown | Unknown |
| Compatibility<br>with Dental<br>Implants | Compatible only with CAMLOG<br>Implant System | Compatible<br>only with<br>Straumann<br>Implant<br>System | Compatible only with<br>Replace Select Dental<br>Implant System from<br>Nobel Biocare |

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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES (USA)" around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 7 2006

Altatec GmbH C/O Ms. Tina Steffanie-Oak Senior Regulatory Affairs Specialist Camlog U.S.A. 520 South Rock Boulevard Reno, Nevada 89502

Re: K051636

Trade/Device Name: Altatec CAMLOG Abutments and Healing Caps Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: January 12, 2006 Received: January 17, 2006

Dear Mr. Steffanie-Oak:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined 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 mierstate commerce pror to that have been reclassified in accordance with the provisions of Amendinents, or to de vees that have Act (Act) that do not require approval of a premarket the rederal I vou, Drag, and Coou may, therefore, market the device, subject to the general approval approvisions of the Act. The general controls provisions of the Act include condors provisions of the existration, 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 (1 WA), it may be subject to back and frederal Regulations, Title 21, Parts 800 to 898. In your device can be found in ther announcements concerning your device in the Federal Register.

{8}------------------------------------------------

Page 2 -- Ms. Steffanie-Oak

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA S issualled of a baseaan. In the complies with other requirements mean that FDA has made a decemmanding administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by section was increasing to of the Act or ally Federal statutes and regulations, but not limited to: registration You must comply with an the Fee s required to the Part 801); good manufacturing practice and ifsing (21 CFR Part 607), laboling (21 CFR Part 820) regulation (21 CFR Part 820); and if requirements as set forum in the quality browns (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 5 0 (k) This letter will anow you to begin maileding , but substantial equivalence of your device to a premarket notification. The I Dr Imaning of otsecation 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 advice for Jour de at [phone]. Also, please note the regulation please contact the Other of Comphanes are (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general miormation of Consumer Assistance at its toll-free Dribber [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Suan Quase

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

{9}------------------------------------------------

# Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Altatec CAMLOG Abutments and Healing Caps

Indications for Use:

CAMLOG implants are used to support dental prostheses in the upper and lower jaws.
The support of the contract and contraction of partially edentylous CAMLOG implants are used to support dethatic oral restoration of partially edentulous and They may be used for functional and destriction of complete prostheses, which are
edentulous jaws using crowns, bridges, partial or complete prostheses, which are
s and the w edentulous Jaws using using suitable components.

CAMLOG Ball Abutments support implant retained mucosa supported overdentures.

CAMLOG Bar Abutments (including bases) support custom milled or prefabricated bars for overdentures.

CAMLOG Healing Caps (Cylindrical, Wide Body, Bottlenesk, and for Bar Abutment) CAMLOG Healing Caps (Cylindical, Wite BAMY OG implant or bar abutment during the displace the gingiva from the space cooked for proper gingiva shaping.

Prescription Use__________________ AND/OR

AND/OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801 Subpart D)

(Per 21 CFR 801 Subpan C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | Suan Pinoy |
|--|----------------------------------------------|
| | Division of Anesthisiology, General Hospital |
| | Infection Control, Dental Devices |
| | 1051636 |

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