← Product Code [NHA](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA) · K102209 # ENCODE PATIENT SPECIFIC ABUTMENT (K102209) _Biomet 3i, Inc. · NHA · Dec 3, 2010 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K102209 ## Device Facts - **Applicant:** Biomet 3i, Inc. - **Product Code:** [NHA](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA.md) - **Decision Date:** Dec 3, 2010 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3630 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Indications for Use BIOMET 3i Patient Specific Dental Abutments (Encode®) Designed Using Cadent iTero Scanner and inLab Software v3.5 are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. These are intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment. ## Device Story Encode® Patient Specific Abutments are custom-designed dental components for endosseous implants. Input consists of 3D intra-oral optical scans (via Cadent iTero Scanner) or resin model scans. Data is processed using inLab Software v3.5 to generate digital design files. Abutments are machined/milled from titanium alloy or ceramic based on these files. Used in dental clinics; operated by dental professionals. Output is a patient-specific abutment supporting screw- or cement-retained prostheses. Device facilitates prosthetic restoration, improving functional and aesthetic outcomes for patients with missing teeth. ## Clinical Evidence Bench testing only. Validation performed on scanning equipment and software to ensure accuracy of scanning models and that the resulting design meets the specifications established in predicates K032263 and K052648. ## Technological Characteristics Materials: Titanium alloy or ceramic. Principle: CAD/CAM design based on 3D optical or model scans. Connectivity: Digital file transfer from scanner to milling system. Software: inLab v3.5 for abutment design. ## Regulatory 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 - BIOMET 3i - Encode® Patient Specific Dental Abutments ([K032263](/device/K032263.md)) - BIOMET 3i - Encode® Patient Specific Dental Abutments ([K052648](/device/K052648.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ BIOMET 3i Traditional 510(k) Patient Specific Dental Abutments (Encode) Designed Using Cadent iTero Scanner and inLab Software v3.5 K102209 DEC 3 2010 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92 510(k) Summary Submitter: BIOMET 3i 4555 Riverside Drive Palm Beach Gardens, FL 33410 1038806 Establishment Reg. Number: Contact Person: Simeon Simone, Regulatory Affairs Specialists Contact Phone/Fax/Email: Tel. 561-776-6831 Fax. 561-383-3407 Email: simeon.simone@biomet.com Date Prepared: August 2nd , 2010 Trade/Proprietary Name: Encode® Patient Specific Abutments Common/Usual Name: Classification Name: Dental Abutment Endosseous Dental Implant Abutment Device Classification/Code: 872.3630 Predicate Device(s) : BIOMET 3i - Encode® Patient Specific Dental Abutments K032263 & K052648 {1}------------------------------------------------ . Patient Specific Dental Abutments (Encode®) Designed Using Cadent iTero Scanner and inLab Software v3.5 #### Device Description: Indications for Use: Performance Data: Equivalence Data: Encode® Abutments are designed specifically for a patient in a CAD/CAM system. The abutments are designed from a three-dimensional intra-oral optical scan or resin model scan and then machined/milled according to the parameters created in a digital file which is derived from the scan. The abutments are manufactured from titanium alloy or ceramic. BIOMET 3i Patient Specific Dental Abutments (Encode®) Designed Using Cadent iTero Scanner and inLab Software v3.5 are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. These are intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment. Validation performed on scanning equipment and software to ensure accuracy of scanning models to produce the intended design as cleared in K032263 & K052648. BIOMET 3i Patient-Specific Dental Abutments (Encode ) have the same intended use and indications, principles of operation, and technological characteristics as previously cleared BIOMET 3i Patient-Specific Dental Abutments. The differences in scanning and CAD/CAM processes do not raise any new questions of safety or effectiveness. Validation data demonstrates that the modified process results in a finished device that is as safe and effective as BIOMET 3i 's Patient-Specific Patient-Specific Dental Abutments that are currently cleared with previous scanner systems. Thus, the BIOMET 3i Patient-Specific Dental Abutments are substantially equivalent to its predicate devices. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows a logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. To the right of the seal is a stylized symbol featuring three abstract shapes, possibly representing people or services, stacked on top of each other. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Mr. Simeon Simone Regulatory Affairs Specialists BIOMET 31, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410 DEC - 3 2010 Re: K102209 Trade/Device Name: BIOMET 3i Patient Specific Dental Abutments (Encode®) Designed Using Cadent iTero Scanner and inLab Software v.3.5 Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: November 19, 2010 Received: November 23, 2010 Dear Mr. Simone: 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. Simone 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 (OS) 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.htm. Sincerely yours. . Nh 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}------------------------------------------------ BIOMET 3i Traditional 510(k) Patient Specific Dental Abutments (Encode®) Designed Using.Cadent iTero Scanner and inLab Software v3.5 # Indications for Use 510(k) Number (if known): Device Name: BIOMET 3i Patient Specific Dental Abutments (Encode®) Designed Using Cadent iTero Scanner and inLab Software v.3.5 Indications for Use: BIOMET 3i Patient Specific Dental Abutments (Encode®) Designed Using Cadent iTero Scanner and inLab Software v3.5are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. These are intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw 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) 0:02 € - (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Page 15 of 393 --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K102209](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K102209) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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