AEDIS(TM)

K100902 · Embed Technology, LLC · DZE · Jun 24, 2010 · Dental

Device Facts

• Record ID: K100902
• Device Name: AEDIS(TM)
• Applicant: Embed Technology, LLC
• Product Code: DZE · Dental
• Decision Date: Jun 24, 2010
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

AEDIS ™ provides a self tapping titanium screw indicated for immediate transitional splinting stability, or long term intra-bony applications such as fixation of new or existing crown, bridge or denture installations in partially or fully edentulous mandibles and maxillae. Immediate loading is not recommended where there is inadequate stability. Immediate loading should occur when the position of the implant provides adequate bone quality and quantity to allow proper immediate mechanical stabilization of the self tapping screw into the bone, and where occlusal and lateral forces can be limited with appropriate occlusal design when splinted. Dietary restrictions may also be required by the surgeon performing the implant procedure.

Device Story

AEDIS is a titanium alloy, root-form endosseous dental implant system. Components include a 1.8 mm diameter self-tapping screw, a cone-shaped abutment, and a cap screw. Used by licensed dentists/surgeons in clinical settings for single or multiple tooth restorations. The implant is surgically placed into the mandible or maxilla; the abutment is mechanically affixed to the screw to support prosthetic appliances (crowns, bridges, dentures). The system provides mechanical stabilization for immediate or long-term loading. Benefits include restoration of dental function and aesthetics. Kit includes surgical instruments (tissue punch, leveling bit, insertion tools). The device is supplied sterile; practitioners may autoclave prior to use.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence demonstrated through comparative testing of materials, design, and mechanical performance against predicate devices.

Technological Characteristics

Material: Titanium alloy. Design: Root-form, self-tapping screw (1.8 mm diameter, 13.5/15 mm length). Abutment: Cone-shaped, 8 mm height, hexagonal fitment. Sterilization: Sterile (autoclavable). Connectivity: None. Software: None.

Indications for Use

Indicated for partially or fully edentulous patients requiring dental restoration (crown, bridge, or denture) in mandibular or maxillary locations. Used for immediate transitional splinting or long-term intra-bony fixation. Contraindicated where inadequate bone stability exists for immediate loading.

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

• Imtec 1.8 mm diameter implant (K031106)
• Intra-Lock 2 mm diameter implant (K070602)
• Sendax MDI 1.8 mm diameter implants (3972351, K990983, K023067)

Submission Summary (Full Text)

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EMBED TECHNOLOGY LLC

# SECTION 4

K100902

| 510 (K) SUMMARY AND CERTIFICATION (As required by 21 CFR 807.92 c) | | JUN 2 4 2010 |
|--------------------------------------------------------------------|-------------------------------------------------------------|--------------|
| March 30, 2010; amended June 8th, 2010 | | |
| 1. Submitter's Name and Contact person | | |
| EMBED Technology LLC | Howard Stamer: Managing Member | |
| 9 East Main Street | | |
| Flemington NJ 08822 | T: 312 265 0065 (direct line) 908 782 3040 (general office) | |
| 2. General information | | |
| Trade Name | (Adams Embed Dental Implant System) AEDIS ™ | |
| Common Name | Endosseous Dental Implant System (screw type) | |
| Classification Name | Endosseous Implant | |
| Device Classification | Class II | |
| Product Code | DZE | |

Identification of Predicate Device: Imtec 1.8 mm diameter implant K031106; (See too Intra-Lock 2 mm diameter implant K070602; Sendax MDI 1.8 mm diameter implants 3972351; K990983; and K023067.)

This submission is an abbreviated 510 (k) as discussed in the FDA's guidance document entitled "The New 510(k) Paradigm - Alternative Approaches to Demonstrating Substantial Equivalence in Premarket Notifications". Embed Technology LLC has provided information to demonstrate conformity with FDA's guideline document entitled Endosseous Implants 872-3640.

## 3. Device Description

The device is a Titanium alloy, root form implant system consisting of: a self-tapping 1.8 mm diameter implant screw with an integrated hexagonal fitment for attachment of an abutment, and a cap screw designed to lock the abutment to the implant screw. AEDIS™ abutments are not angled.

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AEDIS ™ follows natural tooth morphology and is recommended for use in mandibular and maxillary anterior locations for restoration applications. The screw diameter is 1.8mm and is offered in lengths of 13.5 and 15mm. A minimally invasive procedure allows for immediate placement, and temporization in single and multiple tooth restorations. The implant screws are self tapping.

A titanium abutment is provided and is intended to be mechanically affixed to the screw to hold a crown, bridge, or other prosthetic appliance. The prosthesis may be secured to the abutment by the use of adhesives or mechanically by the use of a screw. The abutment is cone shaped; 8 mm in height; has a hexagonal fitment to provide for the cap screw) to lock the abutment the implant screw. The 5 mm diameter of the base of the abutment is identical to the diameter of the top of the implant screw. When all elements of the system are attached to each other the tolerances between the parts are 3 microns or less.

Immediate loading is not recommended where there is inadequate stability. Immediate loading should occur when the position of the implant provides adequate bone quality and quantity to allow proper immediate mechanical stabilization of the self tapping screw into the bone, and where occlusal and lateral forces can be limited with appropriate occlusal design when splinted. Dietary restrictions may also be required by the surgeon performing the implant procedure.

AEDIS™ is offered in a kit including: implant components; surgical instruments; a tissue punch, leveling bit, and implant insertion instruments. The package also includes recommended surgical protocols, and illustration of recommended insertion techniques. The kit is packaged in a plastic container with appropriate labeling. The AEDIS ™ is delivered in sterile condition, however many practitioners also autoclave the device in their own Operatories.

### 4 Indications for Use

AEDIS ™ provides a self tapping titanium screw indicated for immediate transitional splinting stability, or long term intra-bony applications such as fixation of new or existing crown, bridge or denture installations in partially or fully edentulous mandibles and maxillae.

Immediate loading is not recommended where there is inadequate stability. Immediate loading should occur when the position of the implant provides adequate bone quality and quantity to allow proper immediate mechanical stabilization of the self tapping screw into the bone, and where occlusal and lateral forces can be limited with appropriate occlusal design when splinted. Dietary restrictions may also be required by the surgeon performing the implant procedure."

7

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#### EMBED TECHNOLOGY LLC

## 5. Substantial Equivalence Comparisons

EMBED has provided test results and related scientific data demonstrating the substantial equivalence of the !MTEC predicate device and AEDIS™.

The fundamental scientific technology of the device is identical with or very similar to the referenced predicate devices. All materials, processing methods, packaging and sterilization methods are identical with those commonly used in the industry and the predicate devices. The subject and the predicate devices are either identical or substantially equivalent in size and materials, and all offer an abutment system for restorations. The Imtec predicate device and AEDIS packaging inserts each provide a dentist with the surgical protocols for use; pictorial examples of placement; the locations for insertion of anterior and posterior implants. The subject device and the predicates are distributed only to licensed dentists and doctors. EMBED has provided test results demonstrating the substantial equivalence of AEDIS™ and the predicate device. The tests were performed at an independent, highly qualified laboratory who certified the accuracy of the test results.

# Summary of the technological characteristics of AEDIS™ and the predicate device

| Device Name | AEDIS™ | |
|-----------------------|----------------|----------------|
| IMTEC 1.8 MDI implant | | |
| Product Code | DZE | DZE |
| 510(k) | K 100902 | K031106 |
| Material | Titanium Alloy | Titanium Alloy |
| Biocompatibility | Biocompatible | Biocompatible |
| Sterility | Sterile | Sterile |

-

Self tapping titanlum threaded screws indicated for long term intra-Intended use: bony applications. Additionally MDI may also be used for intra-radicular transitional application

There are no new issues of safety or effectiveness presented by the subject device.

8

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## CONCLUSION

The predicate devices and similar implants have not disclosed any safety or health risks. There is no difference in design, materials, or indicated use of the subject device and the cited predicate or similar devices.

Based on the indications for use; results of testing under third party supervision; technological characteristics and comparison to predicate devices, the Adams Embed Dental Implant System AEDIS ™ has been shown to substantially equivalent to the predicate device and therefore safe and effective for its intended use. No new or additional issue of effectiveness or risk to health is raised by the AEDIS™ device

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services USA. The logo features the department's emblem, which is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the emblem in a circular fashion. The emblem is black, and the text is also black.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Embed Technology LLC C/O Mr. Howard Stamer 161 East Chicago Avenue, Suite 37F Chicago, Illinois 60611

JUN 2 4 2010

Re: K100902

Trade/Device Name: AEDIS ™ Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: June 10, 2010 Received: June 10, 2010

Dear Mr. Stamer:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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- Mr. Stamer

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Susan Runnes

( Anthony D. Watson, B.S., M.S., M.B.A. 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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# SECTION 1

# Indication for Use

"AEDIS ™ provides a self tapping titanium screw indicated for immediate transitional splinting stability, or long term intra-bony applications such as fixation of new or existing crown, bridge or denture installations in partially or fully edentulous mandibles and maxillae.

Immediate loading is not recommended where there is inadequate stability. Immediate loading should occur when the position of the implant provides adequate bone quality and quantity to allow proper immediate mechanical stabilization of the self tapping screw into the bone, and where occlusal and lateral forces can be limited with appropriate occlusal design when splinted. Dietary restrictions may also be required by the surgeon performing the implant procedure."

510(k) Number (if known): K# 100902

Device Name: Adams Embed Dental Implant System (AEDIS™)

Concurrence of CDRH Office of Device Evaluation Susan Runner

Prescription Use: -X

(per 21 CFR 801.109)

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

510(k) Number: K160922