TAPERED SCREW-VENT T IMPLANT, TAPERED SCREW-VENT P IMPLANT

K101880 · Zimmer Dental, Inc. · DZE · Oct 1, 2010 · Dental

Device Facts

Record IDK101880
Device NameTAPERED SCREW-VENT T IMPLANT, TAPERED SCREW-VENT P IMPLANT
ApplicantZimmer Dental, Inc.
Product CodeDZE · Dental
Decision DateOct 1, 2010
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3640
Device ClassClass 2
AttributesTherapeutic

Intended Use

The Tapered Screw-Vent® T Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. The Tapered Screw-Vent® P Implants are designed for use in the maxilla or mandible for loading after a conventional healing period. Implants may be used to replace one or more missing teeth.

Device Story

Endosseous dental implants; titanium alloy construction; Tapered Screw-Vent T features MTX surface texture and collar grooves; Tapered Screw-Vent P features MTX texture, collar grooves, and Cancellous-Structured Titanium (CSTi) porous coating for bone ingrowth. Implants are tapered with triple-lead threads to facilitate implantation and osseointegration. Used by dental clinicians in clinical settings to replace missing teeth. Output is the physical implant structure integrated into the jawbone to support prosthetic teeth. Benefits include restoration of dental function and aesthetics.

Clinical Evidence

No clinical studies were conducted. Substantial equivalence is supported by bench testing performed in accordance with FDA guidance for root-form endosseous dental implants.

Technological Characteristics

Endosseous dental implants; titanium alloy; Cancellous-Structured Titanium (CSTi) coating; MTX surface treatment; tapered body with triple-lead threads; 4.7mm and 6.0mm diameters; non-software device.

Indications for Use

Indicated for patients requiring replacement of one or more missing teeth in the maxilla or mandible. Tapered Screw-Vent T Implants allow for immediate loading (with good primary stability/occlusal load) or conventional loading. Tapered Screw-Vent P Implants are indicated for conventional loading only.

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

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Zimmer Dental. The logo features a stylized letter Z inside of a circle. Below the circle is the word "zimmer" in a bold, sans-serif font, with a line underneath it, and the word "dental" in a smaller, sans-serif font below the line. | Zimmer Dental | |---------------| |---------------| 1900 Aston Avenue Carlsbad. CA 92008 760.929.4300 (ph) 760.431.7811 (fax) 510k No .: A5-1 Page No .: 2010 OCT 1 10/880 ## Traditional 510(k) PRE-MARKET NOTIFICATION 510(k) # 510(k) SUMMARY (21CFR807.92(a)) - 1. Submitter's Information: Zimmer Dental Inc. Name: 1900 Aston Ave. 1900 Aston Ave. Address: Carlsbad, CA 92008 760-929-4300 Phone: Contact: Melissa Burbage Date Prepared: June 29, 2010 - 2. Device Name: Tapered Screw-Vent® T Implant and Tapered Screw-Vent® P Implant Device Classification Name: Endosseous Dental Implant ## 2. Predicate Device(s): - a. Zimmer Dental Tapered Screw-Vent® Implant System - i. 510(k) Numbers: K011028 / K953101 / K013227 / K061410 / K072589 - b. NobelReplace Tapered Conical Connection - i. 510(k) Number: K062566 - c. Spline X Implant - i. 510(k). Number: K962576 #### 4. Device Description: The Tapered Screw-Vent® T Implant is an endosseous dental implant. The implant is composed of titanium alloy. The implant section is designed for ease if implantation and with greater surface area for osseointegration. The implant section surface is treated to facilitate osseointegration. In addition, the implant section is tapered with triple-lead threads. The Tapered Screw-Vent® P Implant is an endosseous dental implant. The implant is composed of titanium alloy and Cancellous-Structured Titanium (CSTi) coating. The implant section is designed for ease of implantation and {1}------------------------------------------------ | 510(k) No. | K101880 | |------------|---------| | Page No. | A5-2 | with greater surface area for osseointegration. The CSTi coating is designed to allow for bone ingrowth. The implant section surface is treated to facilitate osseointegration. In addition, the implant section is tapered with triple-lead threads. #### 5. Indications for Use: The Tapered Screw-Vent® T Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. The Tapered Screw-Vent® P Implants are designed for use in the maxilla or mandible for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. #### 6. Device Comparison: The Tapered Screw-Vent® T Implant is the same as the predicate Tapered Screw-Vent Implant in the implant/abutment connection, implant body design, materials, and manufacturing. This device has been modified to add the MTX texture to the top of the implant and add small grooves on the implant collar similar to the predicate NobelReplace Tapered implant. The new device will feature hydroxylapatite coating, hydroxylapatite coating with additional Zimmer Dental MP-1® processing, or MTX surface equivalent to existing Zimmer Dental implants. The new implant will be offered in 4.7mm and 6.0mm diameters. The Tapered Screw-Vent® P implant is the same as the predicate Tapered Screw-Vent® implant in the implant/abutment connection, general implant body design, materials, and manufacturing. The modifications to this device include addition of MTX texture to the top of the implant and the addition of small grooves to the implant collar similar to the predicate NobelReplace Tapered implant. Another modification includes a porous surface created using Cancellous-Structured Titanium (CSTi). This is the same porous surface on the predicate Spline X implant (K962576). The new implant will be offered in 4.7mm and 6.0mm diameters. #### 7. Basis for Substantial Equivalence: The new devices are substantially equivalent to the predicate devices, the indications for Tapered Screw-Vent® T Implant are the same as the Tapered increations for the indications for the Tapered Screw-Vent® P implant have been reduced and only have indications for use in the maxilla or mandible for loading after a conventional healing period. The new devices have the {2}------------------------------------------------ | 510(k) No. | K101880 | |------------|---------| | Page No. | A5-3 | same technological characteristics as the previously cleared predicated devices, and it can be demonstrated that the devices are as safe and effective as the predicate devices. The new devices do not raise any different questions regarding safety and effectiveness as compared to the predicate devices. The Tapered Screw-Vent® T Implant and Tapered Screw-Vent® P Implant, as designed and manufactured, is as safe and effective as the predicate devices and therefore determined substantially equivalent to the referenced predicate devices. #### 7.1 Non-clinical test summary: The new devices have been subjected to bench testing to determine conformance to performance specifications and requirements taking account of its intended use as a dental implant system and following all indications set out in FDA Document "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments". Functional laboratory testing preformed in foreseeable operating conditions showed correct operation of the device per its intended use. ### 7.2 Clinical test summary: No clinical studies were conducted to evaluate the performance of this device. #### 8. Conclusion: We believe that the Tapered Screw-Vent® T Implant and Tapered Screw-Vent® P Implant constitute a safe, reliable and effective dental implant, meeting all the declared requirements of the intended use. The devices present no new adverse health effects or safety risks to patients when used as intended. We conclude that the new devices are safe and effective for the indications for use, and based on the information included in this submission, we believe that substantial equivalence of the proposed devices with the legally marketed predicate devices may be established. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows a logo for the Department of Health & Human Services - USA. The logo is circular and contains the department's symbol, which is a stylized representation of a human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. A dotted line is also present in the image. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 #### DCT 1 2010 Ms. Melissa Burbage Regulatory Affairs Manager Zimmer Dental Incorporated 1900 Aston Avenue Carlsbad, California 92008-7308 Re: K101880 Trade/Device Name: Tapered Screw-Vent® T Implant and Tapered Screw-Vent® P Implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: September 3, 2010 Received: September 14, 2010 Dear Ms. Burbage: 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- Ms. Burbage 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.html 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/Resourcesfor You/Industry/default.htm. Sincerely yours, 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}------------------------------------------------ Image /page/5/Picture/0 description: The image shows a logo for Zimmer Dental. The logo features a stylized letter "Z" inside a circle. Below the circle, the word "zimmer" is written in a bold, sans-serif font. Underneath "zimmer", the word "dental" is written in a smaller, less bold font. Indications for Use 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: Tapered Screw-Vent® T Implant and Tapered Screw-Vent® P Implant Indications For Use: The Tapered Screw-Vent®T Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. The Tapered Screw-Vent® P Implants are designed for use in the maxilla or mandible for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. 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 IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Susan Runos (Division Sign-Off) (Division Sign-Off) Division of Anesthesiology, General Hospital Division of Anesthesion Devices Division of Andolinoon - 30. Infection Control, Dental Devices 510(k) Number: K101880
Innolitics
510(k) Summary
Decision Summary
Classification Order
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