QUANTUM DENTAL IMPLANT SYSTEM

K130787 · Quantum Bioengineering, Ltd. · DZE · Jun 13, 2013 · Dental

Device Facts

• Record ID: K130787
• Device Name: QUANTUM DENTAL IMPLANT SYSTEM
• Applicant: Quantum Bioengineering, Ltd.
• Product Code: DZE · Dental
• Decision Date: Jun 13, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Quantum™ Dental Implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, threaded implants may be immediately loaded when good primary stability is achieved and the functional load is appropriate. Delayed loading is required when using the push-in technique for fin-type or threaded implants. The Ø3.0 mm Quantum Dental Implant is limited to replacement of maxillary lateral incisors and mandibular central and lateral incisors.

Device Story

Quantum™ Dental Implant System consists of root-form, endosseous dental implants; available in threaded or grooved (fin-type) designs; features Morse taper and external hex abutment interface. Implants are placed into maxillary or mandibular bone by dental professionals to support prosthetic restorations (crowns, bridges, overdentures). Threaded implants allow for immediate loading if primary stability is achieved; push-in technique requires delayed loading. 3.0 mm diameter implants are restricted to specific incisor replacement. System provides mechanical foundation for dental prosthetics, restoring oral function and aesthetics for patients with missing teeth.

Clinical Evidence

Bench testing only. Performance demonstrated via static and dynamic compression-bending testing in accordance with ISO 14801.

Technological Characteristics

Root-form endosseous dental implants; titanium alloy construction; Morse taper and external hex abutment interface; threaded or grooved (fin-type) geometry; 3.0 mm diameter; 8, 9, 11, and 14 mm lengths; mechanical fixation; sterilized.

Indications for Use

Indicated for patients requiring dental implants for support of crowns, bridges, or overdentures in the maxillary or mandibular arch. The 3.0 mm diameter implant is specifically indicated for replacement of maxillary lateral incisors and mandibular central and lateral incisors.

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

• Quantum™ Dental Implant System (K112279)
• Quantum™ Versatility Dental Implant System (K002241)
• Quantum Versatility™ Implant System (K991250)
• Bicon Dental Implant System 3.0mm (K101849)
• Astra Tech Implant System (K101732)

Submission Summary (Full Text)

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JUN 1 3 2013

# 510(k) Summary Quantum BioEngineering, Ltd. Quantum™ Dental Implant System K130787

May 20, 2013

#### ADMINISTRATIVE INFORMATION

Manufacturer Name

Quantum BioEngineering, Ltd. 201 N. University Drive, Suite 101 Plantation, FL 33324 Telephone: [phone] Fax: [phone]

Official Contact

Raul R. Mena, D.M.D., President

Representative/Consultant

Linda K. Schulz Floyd G. Larson PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 Telephone: [phone] Fax: [phone] Email: [e-mail] [e-mail]

# DEVICE NAME AND CLASSIFICATION

| Trade/Proprietary Name | Quantum™ Dental Implant System |
|------------------------------------------|------------------------------------------------|
| Common Name | Dental Implant |
| Classification Name | Implant, endosseous, root form |
| Classification Regulations | Class II, 21 CFR 872.3640 |
| Product Code | DZE |
| Classification Panel<br>Reviewing Branch | Dental Products Panel<br>Dental Devices Branch |

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#### INTENDED USE

Quantum™ Dental Implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch for use as support for crowns, bridges or overdentures. Wenn onestage surgical approach is applied, threaded implants may be immediately loaded when good primary stability is achieved and the functional load is appropriate. Delayed loading is required when using the push-in technique for fin-type or threaded implants. The Ø3.0 mm Quantum Dental Implant is limited to replacement of maxillary lateral incisors and mandibular central and lateral incisors.

## DEVICE DESCRIPTION

The Quantum Dental Implant System implants included in this submission are root form, endosseous dental implants with a Morse taper and external hex abutment interface. They are made of titanisous alloy, with three surface options. Implants are provided in both a threaded and a grooved (fin-ype) design. The implants are 3.0 mm in diameter and are available in four lengths (8, 9, 11, & 14 m(1)

## EQUIVALENCE TO MARKETED DEVICE

The Quantum Dental Implant System is substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially quivalent to pre-amendment devices:

K I 12279 - Quantum BioEngineering, Ltd., Quantum™ Dental Implant System K002241 - Quantum BioEngineering, Ltd., Quantum™ Versatility Dental Implant System K991250 - Quantum BioEngineering, Ltd., Quantum Versatility™ Implant System K101849 - Bicon, LLC, Bicon Dental Implant System 3.0mm K101732 - Astra Tech AB, Astra Tech Implant System

The subject device and the predicate devices have intended use and have the same technological characteristics. The subject device and the predicate devices encompass the same range of physial dimensions and characteristics, including implant diameter, length, and surface traatment. Any differences in the technological characteristics between the subject device and the predicate devices do not raise new issues of safety or efficacy.

Performance testing is provided to demonstrate substantial equivalence and includes static and dynamic compression-bending testing according to ISO 14801. The data included in this submission demonstrates substantial equivalence to the predicate devices listed above.

Overall, the Quantum Dental Implant System has the following similarities to the predicate devices:

- . has the same intended use.
- . uses the same operating principle,
- . incorporates the same basic design,
- incorporates the same or very similar materials, and .
- . has similar packaging and is sterilized using the same materials and processes.

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

#### June 13, 2013

Quantum BioEngineering, Limited C/O Ms. Linda Schulz PaxMed International, Limited Liability Company 12264 El Camino Real, Suite 400 SAN DIEGO CA 92130

Re: K130787

Trade/Device Name: Quantum™ Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: May 20, 2013 Received: May 21, 2013

Dear Ms. Schulz:

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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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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

Mary-S.
Susan Runner -S

Kwame Ulmer. M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

K130787 510(k) Number:

Quantum™ Dental Implant System Device Name:

Quantum™ Dental Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, threaded implants may be immediately loaded when good primary stability is achieved and the functional load is appropriate. Delayed loading is required when using the push-in technique for fin-type or threaded implants. The Ø3.0 mm Quantum Dental Implant is limited to replacement of maxillary lateral incisors and mandibular central and lateral incisors.

X Prescription Use (Part 21_CFR 801_Subpart D)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of _

Andrew I. Steen
2013.06.07 14:45:16-04'00'

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

**510(k) Number:** K130787