Who is the manufacturer of LEW MDI O-BALL COLLARED IMPLANT,?

Park Dental Research Corp. filed the 510(k) submission for LEW MDI O-BALL COLLARED IMPLANT, (K121707).

What is the FDA product code for LEW MDI O-BALL COLLARED IMPLANT,?

DZE. It is classified under 21 CFR 872.3640 as a Class 2 device in the Dental panel.

What is the regulatory pathway for LEW MDI O-BALL COLLARED IMPLANT,?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like LEW MDI O-BALL COLLARED IMPLANT,?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

LEW MDI O-BALL COLLARED IMPLANT,

Q: What are the predicate devices for LEW MDI O-BALL COLLARED IMPLANT,?

IMTEC MDI (K031106); Intra-Lock MDL (K070601); Intra-Lock MILO (K050970); Prizmatics Inclusive (K100932).

K121707 · Park Dental Research Corp. · DZE · Sep 24, 2012 · Dental

Device Facts

Record ID	K121707
Device Name	LEW MDI O-BALL COLLARED IMPLANT,
Applicant	Park Dental Research Corp.
Product Code	DZE · Dental
Decision Date	Sep 24, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3640
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Park Dental Research Corporation's LEW O-ball implant system is a self-tapping titanium threaded screw indicated for long-term intra-bony applications. Additionally, the LEW Mini O-ball Implant may be used for inter-radicular transitional applications. These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial edentulism, and employing minimally invasive surgical intervention. The 2.0mm , 2.5 mm, and 3.0 mm diameter are intended to support single or multi-unit restorations in both long-term and temporary applications throughout the maxillary and mandibular arches.

Device Story

LEW Mini O-Ball Implant is a root-form, self-tapping, threaded screw dental implant; manufactured from Ti6Al4V ELI titanium alloy. Available in 2.0mm, 2.5mm, and 3.0mm diameters with optional 1.5mm gingival collar; thread lengths range from 10mm to 18mm. Surface treated via 50-micron aluminum oxide ablation to remove machined finish. Used by dental clinicians in surgical settings to provide immediate splinting stability and long-term fixation for crown and bridge restorations. Implant head features O-ball connection for prosthetic attachment. Device facilitates minimally invasive surgical intervention for edentulous patients.

Clinical Evidence

Bench testing only. Fatigue testing conducted according to ISO 14801 on 2.0mm diameter models to verify mechanical strength compared to predicate devices.

Technological Characteristics

Material: Ti6Al4V ELI (ASTM F 136-02). Surface: Ablated with 50-micron aluminum oxide. Design: Root-form, self-tapping, threaded screw. Diameters: 2.0mm, 2.5mm, 3.0mm. Lengths: 10-18mm. Sterilization: Delivered sterile. Connection: O-ball head, 1.65mm square driver connection.

Indications for Use

Indicated for patients with full or partial edentulism requiring long-term intra-bony fixation or inter-radicular transitional applications. Supports single or multi-unit restorations in maxillary and mandibular arches.

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 MDI (K031106)
Intra-Lock MDL (K070601)
Intra-Lock MILO (K050970)
Prizmatics Inclusive (K100932)

Reference Devices

IMTEC K081653

Related Devices

K110548 — OSI O-BALL ABUTMENT HEAD IMPLANTS · Juell Dental · Jul 29, 2011
K092555 — UNO NARROW IMPLANT · Mis Implants Technologies , Ltd. · Jan 5, 2010
K100932 — INCLUSIVE MINI IMPLANT · Prismatik Dentalcraft, Inc. · Dec 27, 2010
K142260 — NobelActive · Nobel Biocare AB · May 11, 2015
K133613 — INTRA-LOCK DENTAL IMPLANTS · Intra-Lock International, Inc. · Mar 20, 2014

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image is a circular logo with the words "PARK DENTAL" in the center. The text is white and the background is black. The logo is simple and easy to read. 510(k) Summary Submitter: Owner - Park Dental Research Corporation, 2401N. Commerce, Ardmore, OK. Office 212.736.3765, Fax 214.233.7279. Point of Contact - Ron Bulard. Submitted 5/18/2012 Proprietary Name: LEW Mini O-Ball Implant Common/Usual Name : Implants, endosseous implants, SDI's, Small diameter implants Classification Name and Number : Endosseous Dental Implant (21 CFR 872.3640 DZE) Devices for Substantial Equivalence: IMTEC MDI K031106, Intra-Lock MDL K070601, Intra-Lock MILO K050970, Prizmatics Inclusive K100932 #### Device Description The LEW Mini O-ball implant (MD)) is available with a 1.5 mm gingival collar in three diameters: 2.0mm, and 3.0mm. The LEW Mini O-ball implant (MDI) is also available without a gingival collar in two diameters; 2.0mm and 2.5mm. The implant is made of Titanium alloy (Ti6A4V ELI per ASTM F 136-02), The thread surface is ablated with 50 micron aluminum oxide to remove shiny machined surface. The LEW Mini O-ball implant (MDI) is available in thread lengths ranging from 10mm to 18mm allowing for maximum bone engagement. The system consists of the major component, a root-form, screw type, self-tapping implant, and accessories designed to facilitate placing and using the implant. The accessories contact tissues for less than 1 hour and therefore are exempt from 510(k) requirements are described generally but are of course subject to general controls and are covered by the Quality System documents. #### Indications for Use The Park Dental Research Corporation's LEW O-ball implant system is a self-tapping titanium threaded screw indicated for long-term intra-bony applications. Additionally, the LEW Mini O-ball Implant may be used for inter-radicular transitional applications. These devices will permit immediate splinting stability and long-term fixation of new and bridge installations, for full or partial edentulism, and employing minimally invasive surgical intervention. The 2.0mm , 2.5 mm, and 3.0 mm diameter are intended to support single or multi-unit restorations in both long-term and temporary applications throughout the maxillary and mandibular arches. #### Testing Fatigue testing was conducted according to ISO 14801 on both models of 2.0mm implant. Compliance with Performance Standards No performance standards are applicable, however we followed "Class II Special Controls Guidance - Document: Root-form Endosseous Dental Implant Abutments" issued May 12, 2004. The Ti6AlAV-EU titanium used in these implants meet ASTM F-136 "Standard Specifications for Wrought Titanium-6aluminum-4Vanadium Allow for Surgical Implant Applications" Page 1 of 3 {1}------------------------------------------------ ### Substantial Equivalence Summary : The LEW Mini O-Ball implant system is substantially equivalent to several small diameter implants systems currently on the market. We have listed five 510(k) implants systems. A detailed chart of more implant systems is included in Section 12 | Element of Comparison | LEW Mini O-Ball Implant | IMTEC K031106 | IMTEC K081653 | Intra-Lock K070601 | Intra-Lock K050970 | Prismatic K100932 | |-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Diameter (mm) | 2.0, 2.5, 3.0 | 1.8, 2.1, 2.4 | 2.9 | 2.0, 2.5 | 3.0 | 2.2, 2.5, 3.25 | | Length (mm) | 10,13,15,17,18 | 10,13,15,18 | 10,13,15,18 | 10,11.5,13,15,18 | 10,11.5,13,15,18 | 10, 13, 15 | | Implant head shape | O-ball Connection compatible/SE to IMTEC K031106 and Intra-Lock K070601. SE | O-ball Connection compatible to an o-ring metal housing | O-ball Connection compatible to an o-ring metal housing | O-ball Connection compatible/SE to IMTEC K031106 | O-ball Connection compatible/SE to IMTEC K031106 | O-Ball Connection SE to IMTEC K031106 | | Indications for use | The Park Dental Research Corporation's LEW O-ball implant system is a self- tapping titanium threaded screw indicated for long- term intra-bony applications. Additionally, the LEW Mini O-ball Implant may be used for inter- radicular transitional applications. These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial edentulism, and employing minimally invasive surgical intervention. The 2.0mm , 2.5 mm, and 3.0 mm diameter are intended to support single or multi-unit restorations in both long-term and temporary applications | The MDI and MDI Plus are self- tapping titanium threaded screws indicated for long-term intra- bony applications. Additionally, the MDI may be used for inter-radicular transitional applications. These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial edentulism, and employing minimally invasive surgical intervention. | The MII Implant is intended to support single or multi-unit restorations in both long-term and temporary applications throughout the maxillary and mandibular arches. The MII implant is indicated for immediate loading when good primary stability is achieved. Additionally, this device will permit stability and long term fixation of upper and lower dentures in edentulous cases. | 3. Mini Drive-Lock™ Dental Implants are intended for use as a self-tapping titanium screw for transitional or intra- bony long-term applications. 4. Mini Drive-Lock™ Dental Implants are indicated for long- term maxillary and mandibular tissue supported denture stabilization. Multiple implants should be used and may be restored after a period of time or placed in immediate function. | MILO ™ Implants are indicated for long-term maxillary and mandibular tissue-supported denture stabilization. Multiple implants may be restored after a period of time or placed in immediate function. | Inclusive® Mini Implants are self- tapping threaded titanium screws indicated for long- term applications. Inclusive® Mini Implants may also be used for provisional applications. These devices will allow immediate loading and long- term stabilization of dentures and provisional stabilization of dentures while standard implants heal. To be used for immediate loading only in the presence of primary stability and appropriate occlusal loading. | | Element of Comparison | LEW Mini O-Ball Implant throughout the maxillary and mandibular arches. | IMTEC K031106 | IMTEC K081653 | Intra-Lock K070601 | Intra-Lock K050970 | Prismatic K100932 | | Material | Ti6Al4V ASTM F-136 | Ti6Al4V ASTM F- 136 | Ti6Al4V ASTM F- 136 | Ti6Al4V ASTM F-136 | Ti6Al4V ASTM F- 136 | Ti6Al4V ASTM F- 136 | | Sterilization | Delivered sterile | Delivered sterile | Delivered sterile | Delivered sterile | Delivered sterile | Delivered sterile | | Packaging | Vial in a pouch | Vial in a pouch | Vial in a pouch | Vial in a pouch | Vial in a pouch | Vial in a pouch | | Product Code | dze | dze | dze | dze | dze | dze | | Screw pitch & depth of thread | Thread pitch ranges between IMTEC's fine and coarse pitch as well as thread depth | Fine thread pitch for 1.8,2.1 Diameters. Ccoarser pitch for 2.4 | Coarse Pitch and depth | Thread pitch ranges between IMTEC's fine and coarse pitch as well as thread depth | Coarse Pitch and depth | Coarse Pitch and depth | | Bone Contact Surface | Blasted and clean (SLA equivalent), machined surface, SE to IMTEC K031106 | Blasted and clean (SLA equivalent), machined surface | Blasted and clean (SLA equivalent), machined surface | Blasted and clean, , SE to IMTEC K031106, In addiion with embedded CaPhos molecules | Blasted and clean, , SE to IMTEC K031106, In addiion with embedded CaPhos molecules | Blasted Etched Surface, SE to IMTEC K031106 | | Driver Connection | Square 1.65mm SE to IMTEC K031106 | Square 1.65mm | Square 1.65mm | Square 1.65mm SE to IMTEC K031106 | Square 1.65mm SE to IMTEC K031106 | Square 1.65mm SE to IMTEC K031106 | | Included Prosthetic | Metal Housing(s) with o-ring, SE to IMTEC K031106 | Metal Housing(s) with o-ring, | Metal Housing(s) with o-ring, | Metal Housing(s) with o-ring, SE to IMTEC K031106 | Metal Housing(s) with o-ring, SE to IMTEC K031106 | Metal Housing(s) with o-ring, SE to IMTEC K031106 | | Fatigue testing | Tested to ISO 14801 (results attached) . The LEW Mini O-Ball implant is substantially equivalent or stronger* than IMTEC's K031106 MDI implant. The same titanium alloy, a SE of thread pitch, form and depth, a SE of threaded lengths. *Tthe IMTEC MDI 1.8mm diameter is approved, when calculated has a lower fatigue properties than a SE 2.0mm diameter implant | In clinical use since 1998 | In clinical use since 2008 | SE to IMTEC K031106 | SE to IMTEC K081653 | SE to IMTEC K031106 | Page 2 of 3 {2}------------------------------------------------ . · . 1999 - 1999 - 1999 . Page 3 of 3 : {3}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/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 or bird-like symbol with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 2017 Park Dental Research Corporation Mr. Ronald Bulard President 2401 North Commerce Street, Suite B Ardmore, Oklahoma 73401 Re: K121707 Trade/Device Name: Lew Mini O-Ball Implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: August 27, 2012 Received: September 4, 2012 Dear Mr. Bulard: 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. {4}------------------------------------------------ Page 2- Mr. Bulard 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm1. Sincerely yours, An for 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 {5}------------------------------------------------ # Indications for Use 510(k) Number (if known): K121707 Device Name: LEW Mini O-Ball Implant Indications for Use: The Park Dental Research Corporation's LEW O-ball implant system is a self-tapping titanium threaded screw indicated for long-term intra-bony applications. Additionally, the LEW Mini O-ball Implant may be used for inter-radicular transitional applications. These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial edentulism, and employing minimally invasive surgical intervention. The 2.0mm , 2.5 mm, and 3.0 mm diameter are intended to support single or multi-unit restorations in both long-term and temporary applications throughout the maxillary and mandibular arches. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Susan Russo (Division Sign-Off) (Division Sign-Off) Division of Anestheslology, General Hospital Infection Control, Dental Devi 510(k) Number: Page 1 of

LEW MDI O-BALL COLLARED IMPLANT,

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

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LEW MDI O-BALL COLLARED IMPLANT,

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

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