Who is the manufacturer of ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE?

Biomet 3i, Inc. filed the 510(k) submission for ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE (K110565).

What is the FDA product code for ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE?

NHA. It is classified under 21 CFR 872.3630 as a Class 2 device in the Dental panel.

What is the regulatory pathway for ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE?

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

What are the predicate devices for ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE?

Nobel Replace HA Coated Implant (K020646); Atlantis Abutment for Nobel Replace Interface (K053654); Replace TiUnite Endosseous Implant (K023113).

Who can help prepare an FDA 510(k) submission like ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE?

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.

ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE

K110565 · Biomet 3i, Inc. · NHA · Sep 1, 2011 · Dental

Device Facts

Record ID	K110565
Device Name	ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE
Applicant	Biomet 3i, Inc.
Product Code	NHA · Dental
Decision Date	Sep 1, 2011
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2
Attributes	Therapeutic

Intended Use

BIOMET 3i Dental Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw retained or cement retained to the abutment.

Device Story

The BIOMET 3i Encode Patient Specific Abutment is a dental prosthetic component designed to interface with Nobel Replace connection implants. It serves as an accessory to endosseous dental implants, supporting screw-retained or cement-retained single or multiple tooth prostheses. The device is milled from titanium alloy and allows for limited design input from dental laboratories to match patient-specific anatomical requirements, with a maximum angulation of 15°. It is used by dental professionals to restore function and aesthetics in edentulous patients. The device functions by connecting the dental implant to the final prosthetic restoration, facilitating the transition from the implant platform to the oral environment.

Clinical Evidence

Bench testing only. Performance testing was conducted in accordance with the Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments. Testing compared the proposed system to predicate systems, with results meeting or exceeding established acceptance criteria.

Technological Characteristics

Milled titanium alloy abutment; designed for Nobel Replace implant connection; maximum angulation 15°; supports screw or cement-retained prostheses. No software or electronic components.

Indications for Use

Indicated for partially or completely edentulous patients requiring single or multiple tooth prosthetic support in the mandible or maxilla via endosseous dental implants.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). 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.)

Predicate Devices

Nobel Replace HA Coated Implant (K020646)
Atlantis Abutment for Nobel Replace Interface (K053654)
Replace TiUnite Endosseous Implant (K023113)

Related Devices

K120776 — ABUTMENT FOR COMPETITIVE IMPLANT NOBEL ACTIVE CONNECTION · Biomet 3i · Sep 11, 2012
K071439 — ZIMMER PATIENT-SPECIFIC ABUTMENT, INTERNAL HEX, TITANIUM · Zimmer Dental, Inc. · Sep 20, 2007
K112730 — ABUTMENT FOR COMPETITIVE IMPLANT STRAUMANN BONE LEVEL CONNECTION · Biomet 3i · Jan 13, 2012
K151039 — ATLANTIS Abutment for NobelActive 3.0 · Dentsply International, Inc. · Jan 14, 2016
K143051 — ArgenIS Titanium Abutments · The Argen Corporation · Sep 16, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ と r i ﻬ ### BIOMET 31, Traditional 510(k) Premarket Notification - BIOMET 3i Encode Patient Specific Abutment for Nobel Replace Connection BIOMET **3i** SEP - 1 2011 ## 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.93 | Submitter: | BIOMET 3i 4555 Riverside Drive Palm Beach Gardens, FL 33410 | |------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Establishment Registration Number: | 1038806 | | Contact: | Jose E. Cabrera Sr. Manager, Regulatory Affairs BIOMET 3i 4555 Riverside Drive Palm Beach Gardens, FL 33410 Tel. 561-776-6840 Fax. 561-514 6316 Email jose.cabrera@biomet.com | | Date Prepared: | 08/27/2011 | | Trade/Proprietary Name: | Encode Patient Specific Abutment with Nobel Replace Connection | | Common/Usual Name: | Dental Implant Abutment | | Classification Name: | Abutment, implant, dental, endosseous | | Device Classification/ Code: | Class II 21 CFR §872.3630 / NHA | | Predicate Device: | K020646, Nobel Replace HA Coated Implant K053654, Atlantis Abutment for Nobel Replace Interface K023113, Replace TiUnite Endosseous Implant | | Performance Testing: | Performance testing was conducted as per Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental | {1}------------------------------------------------ ## BIOMET 3i, Traditional 510(k) Premarket Notification – BIOMET 3i Encode Patient Specific Abutment for Nobel Replace Connection : : | Abutments. Performance testing was based on a comparison between proposed and predicat implant/abutment systems. The results were equal o better than established acceptance criteria, wher predicate testing was used as a baseline. Compatibilit testing for the abutment will be performed every 6 months. | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Description: | BIOMET 3i Encode Patient Specific Abutment for Nobel Replace Connection can be compared to current Encode Patient Specific abutments. The change to this device is only to the connection that is intended to interface which is identical to the interface found on the Nobel Replace HA Coated Implant. This feature does not modify the intended functionality of the implant/abutment system. This device is also intended for dental laboratories to provide limited design input to match the anatomical requirements of the patient. Maximum angulation for the abutment is limited to 15°. | | Indications for Use: | BIOMET 3i Dental Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw retained or cement retained to the abutment. | | Technological Characteristics | BIOMET 3i Encode Patient Specific Abutment for Nobel Replace Connection is milled from titanium alloy, is attached to a dental implant and is indicated for the same intended use as the predicated devices reference within this pre-market notification. | | Conclusion: | BIOMET 3i Encode Patient Specific Abutment for Nobel Replace Connection is substantially equivalent to the legally marketed predicates | {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Mr. Jose E. Cabrera Senior Regulatory Affairs Manager BIOMET 3i. Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410 SEP - 1 2011 Re: K110565 Trade/Device Name: BIOMET 3i Encode Patient Specific Abutment for Nobel Replace Connection Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: August 29, 2011 Received: August 31, 2011 Dear Mr. Cabrera: 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. {3}------------------------------------------------ #### Page 2 - Mr. Cabrera 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 l'ederal 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/Resourcesfor You/Industrv/default.htm. Sincerely yours. hh 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 {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): KIlO565 ## Device Name: BIOMET 3i Encode Patient Specific Abutment for Nobel Replace Connection Indications for Use: BIOMET 3i Dental Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw retained or cement retained to the abutment. | 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) | (Division Sign-Off) | | |-----------------------------------------------------------------------------------|---------| | Division of Anesthesiology, General Hospital Infection Control, Dental Devices | | | 510(k) Number: | K110565 | 22