ALMITECH INC. DENTAL IMPLANT SYSTEM

K052733 · Almitech, Inc. · DZE · Dec 22, 2005 · Dental

Device Facts

• Record ID: K052733
• Device Name: ALMITECH INC. DENTAL IMPLANT SYSTEM
• Applicant: Almitech, Inc.
• Product Code: DZE · Dental
• Decision Date: Dec 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The implant system is intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth, freestanding bridges and to retain over dentures by means of o-ring abutments or bar-attachments

Device Story

Almitech Dental Implant System is an endosteal root-form (cylindrical) implant system used for single-stage or two-stage surgical placement in the jaw. Implants are precision-machined from grade-4 pure titanium or medical-grade titanium alloy, featuring fine pitch threads, spherical tips, and two cutting grooves for self-tapping. The surface is sandblasted with calcium phosphate abrasive. The internal connection utilizes an 8° Morse taper with three cutouts for positioning and a threaded hole for abutment delivery. Components include cover screws, healing caps, and various abutment systems (solid or o-ring). Surgical instruments (drills, drivers, torque wrenches) are used by dental clinicians to place the implant and secure the abutment. The system provides a stable foundation for prosthetic restorations, benefiting patients by restoring function and aesthetics in edentulous or partially edentulous areas.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Endosteal root-form implant; material: CP Titanium Grade 4; surface: sandblasted with calcium phosphate abrasive (Ra=70μIN); connection: 8° Morse taper; sterilization: Gamma; components: implants, cover screws, healing caps, abutments; surgical instruments included.

Indications for Use

Indicated for surgical placement in the upper or lower jaw of patients requiring prosthetic attachment for single tooth restorations, partially or fully edentulous spans with multiple single teeth, freestanding bridges, or overdentures retained by o-ring or bar-attachments.

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

• ITI Solid screw implant (K894593)
• ITI Solid screw implant (K894595)
• ITI Solid screw implant (K971578)
• ITI Solid screw implant (K920768)
• Blue Sky Bio Dental Implant System (K010882)
• Paragon Screw-Vent System (K950578)
• Paragon Screw-Vent System (K861426)

Submission Summary (Full Text)

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K052733

### DEC 2 2 2005

### 510(k) Summary of Safety and Effectiveness II.

Company Name:

Almitech Inc. 2643 Bellmore, NY 11710 USA

Contact Name:

Alex Breytman President Phone: [phone] [phone] Fax:

Date Prepared: (9)/(25/2005

## 2.1 Device Name:

Proprietary name: Almitech Inc. Dental Implant System Common/Usual Name: Endosseous Dental Implant Trade Name: Almitech Inc. Dental Implant System

The device has been classified in Class II under the following classification:

| Classification name | Product Code | Regulation Number | Panel Identification |
|---------------------|--------------|-------------------|----------------------|
| Endosseous Implant | DZE | 872.3640 | Dental Devices Panel |

## 2.2 Description of the Device:

Almitech is an Endosteal Root-form (Cylindrical) Implant. The implant system consists of multiple components that are precision-machined and are manufactured from grade-4 pure titanium or a medical grade titanium alloy.

Implants: Almitech implant (See attachment 5, 6, 7) is intended for cither single-stage or two-stage surgical placement. Implant consist of fine pitch threads with 60° profiles, spherical tips and have two cutting grooves that give the implant its self-tapping feature. The outside surface is sandblasted with calcium phosphate abrasive to create surface roughness about Ra= 70μIN. (See Blasted surface information Attachment 1, 2, 3, 4). The inside of the implant consists of 8° Morse taper with three cutouts to drive it in place and provide positioning to abutment and threaded hole to deliver abutment in to place.

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Cover screw / healing caps: The cover screws and healing caps (See attachment 8, 9) are manufactured from grade 4 titanium and are placed in the implant using a Hex Tool. Using the 1.25mmD Hex Tool, by carrying the cover screw/healing cap to the surgical site thread it into the implant. Suture the soft tissue over the implant or around the cover screw (healing cap) or transmucosal neck. The cover screw/ healing cap keeps free from ingrowth of bone and soft tissue as well accumulating debris by occluding the internal surface of the implant. The parts are found freely floating inside a sterile individual Tyvek pouches.

Abutment systems and superstructures: The abutment (See attachment 10, 11) selection process occurs at the start of the prosthetic procedure and is dependent on the measurement of gingival thickness. After adequate osseo-integration the implants should be uncovered if necessary and the cover screw should be removed. The internal part of the implant irrigated. freed from debris and dried. The appropriate abutment should be placed, by using an inserting driver (1.25mmD Hex Tool) and a torque wrench applying 30 Ncm of torque. Once the abutment is fit on the implant, it delivers maximum stability with the use of the torque wrench.

Solid Abutments do not have to be modified but can be, and if it is necessary to modify the abutments, carbide or a diamond bur can be used with copious irrigation.

Abutments are not to be over-prepared, taking into consideration retention of restoration and strength of the abutment. It is not recommended to modify the abutment at the junction with implant.

Surgical Instruments: The range of instruments made available as part of the Almitech Inc. Dental Implant System include: drills, adapters, implant inserts, screw drivers, torque ranges, ratchets and metal cassettes for sterilization.

## 2.3 Indications for Use:

The implant system is intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth, freestanding bridges and to retain over dentures by means of o-ring abutments or bar-attachments

## 2.4 Predicate Devices:

The data submitted in this 510(K) is aimed toward demonstrating substantial equivalence of Almitech Inc. Dental Implant System to ITI Solid screw implant (K894593), (K894595), (K971578), (K920768), Blue Sky Bio Dental Implant System (K010882), and Paragon Screw-Vent System (K950578), (K861426). Almitech Inc. Dental Implant System is compatible to the three Dental Implant Systems examined above and all contain implants, cover screws and healing cups, abutments, and the applicable surgical instruments. All other technological characteristics are similar, and all four devices show equivalent performance characteristics.

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| Feature | Almitech Inc. Dental Implant System | ITI Solid screw implant K894593, K894595, K971578, and K920768 | Blue Sky Bio Dental Implant System K010882 | Paragon Screw-Vent System K950578, K861426 |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Material | CP Titanium Grade 4 | CP Titanium Grade 4 | CP Titanium Grade 4 | CP Titanium Grade 4 |
| One Stage | Yes | Yes | Yes | No |
| Coating | Blasted with resorbable medium, HA | TPS | Blasted with resorbable medium | Blasted with resorbable medium, HA |
| Body Diameter (mm) | 3.3, 4.1, 4.8, | 3.3, 4.1, 4.8 | 3.3, 4.1, 4.8 | 3.7, 4.7, 6.0 |
| Collar Diameter (mm) | 3,3;4,1;4.8; 5.6 | 3.5;4.1;4.8, 6.5 | 4.1;4.8, 6.5 | 3.7, 4.7, 6.0 |
| Collar Height (mm) | 1.8 | 1.8, 2.8 | 1.8, 2.8 | 1.0 |
| Lengths (mm) | 8, 10, 12, 14, 16 | 8, 10, 12, 14, 16 | 8, 10, 12, 14 | 8, 10, 13, 16 |
| External Screw Threads | Yes | Yes | Yes | Yes |
| Anti-rotational feature | Internal Taper 8° | Internal Taper 8° | Internal Taper 8° | Internal Hex |
| Gamma Sterilized | Yes | Yes | Yes | Yes |
| Solid Abutment for Cemented Restoration | Yes | Yes | Yes | Yes |
| O-ring Abutment for partial or full overdenture | Yes | Yes | Yes | Yes |
| Instruments (surgical and restorative) | Yes | Yes | Yes | Yes |
| Intended Use | Implantation into the fully or partially edentulous ridge for support of single of multiple unit prosthesis. | Implantation into the fully or partially edentulous ridge for support of single of multiple unit prosthesis. | Implantation into the fully or partially edentulous ridge for support of single of multiple unit prosthesis. | Implantation into the fully or partially edentulous ridge for support of single of multiple unit prosthesis. |

# 2.5 Substantial Equivalence Chart:

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# 2.6 Conclusion:

The evaluation of Almitech Inc. Dental Implant System does not raise any new questions of safety or effectiveness and may therefore be considered substantially equivalent to the predicate devices. ・

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 2 2005

Mr. Alex Breytman President Almitech, Incorporated 2643 Bedell Street Bellmore, New York 11710

Re: K052733

Trade/Device Name: Almitech Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: November 29, 2005 Received: November 30, 2005

Dear Mr. Breytman:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your securer sined 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 mensiale comments, or to that have been reclassified in accordance with the provisions of Amendinens, on to devrees that have over (Act) that do not require approval of a premarket the Federal Pood, Drug, and Cosments , too er fore, market the device, subject to the general approval appliedion (1 May.t. The general controls provisions of the Act include controls provisions of the rice. "The Jisting 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 II your device is classified (500 above) with the existing major regulations affecting (PMA), it may be subject to Sachierial Prail Regulations, Title 21, Parts 800 to 898. In your device can be found in the South of Peaceres oncerning your device in the Federal Register.

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### Page 2 - Mr. Breytman

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 moun that I Dri has made statutes and regulations administered by other Federal agencies. of the Act of ally I ederal states requirements, including, but not limited to: registration Touring (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 807), abolity systems (QS) regulation (21 CFR Part 820); and if requirences as sections are quartify in 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 letter will and n yourse bogan finding of substantial equivalence of your device to a premarket notification. - The PDF 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 active 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 may oventi outer generational 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,

Sylette y. Michie Oms

Čhiu Lin. Ph.D. 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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Page _ 1_ of __ 1

S10(K) Number:

Device Name: Almitech Dental Implant System

## INDICATIONS FOR USE:

The implant system is intended for surgical placement in the upper or lower jaw to
r the support of any the simple and in also tooth restorations and in partially or provide a means for prosthetic attachment in single tooth resorations and in partially or provide a means for prostheic attachment in stigle coomroom bridges and to retain over
fully edentulous spans with multiple single teeth, freestanding bridges and to retain o fully edentulous spans with multiple single single intents

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Dental, Infection Control,

And General Hospital Devices

510(k) Number K052733
Prescription Use X OR

(Per 21 CFR 801.109)

Susan Quonog

Jon Sign-Off) on Sign-Oh)
on of Anesthesiology, General Hospital, ion Control, Dental Devices

310(k) Number: K052733

Over- The-Counter Use

(Optional Format 1-2-96)