(276 days)
No
The description focuses on CAD/CAM design and machining based on scans and predefined parameters, with no mention of AI or ML algorithms for design or analysis.
No
The device is described as an "accessory to endosseous dental implants to support a prosthetic device," indicating its role in supporting a dental prosthesis rather than directly treating a disease or condition.
No
The device is an abutment that supports a prosthetic device. It is not used for diagnosis.
No
The device description clearly states that the device is a physical dental abutment manufactured from titanium alloy or zirconia, which are hardware components. While the design process utilizes software (CAD/CAM system), the final product is a physical medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Encode® Patient Specific Dental Abutments are "intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient." This describes a physical device used in a surgical/dental procedure to support a prosthesis, not a test performed on biological samples to diagnose a condition.
- Device Description: The description details the materials, manufacturing process (CAD/CAM, machining/milling), and physical specifications of the abutments. This aligns with a medical device used for structural support, not an IVD which would involve reagents, calibrators, controls, etc., for analyzing samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
Therefore, the Encode® Patient Specific Dental Abutments are a medical device, specifically a dental implant accessory, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Encode® Patient Specific Dental Abutments made from oral scans provided from Sirona CEREC AC Scanner System and inLab Software v3.65 are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. Encode® Patient Specific Dental Abutments 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.
Product codes
NHA
Device Description
Encode® Patient Specific Dental Abutments are designed specifically for a patient using a CAD/CAM system. The abutments are designed from a threedimensional intra-oral optical scan or resin model scan and then machined/milled according to the parameters created in a digital file which are derived from the scan. The abutments are manufactured from titanium alloy (Ti 6Al-4V ELI) or biocompatible Zirconia TZP. The abutment design is limited according to BIOMET 3i Specifications, as follows:
A.) Platform Seating Diameter Min. 3.4 mm Max. 6.0mm
B.) Gingival Margin Diameter Min. 3.8mm Max. 16.0mm
C.) Gingival Margin Height External Hex 3.4mm Platform Min. 0.5 mm Max. N/A
C.) Gingival Margin Height Certain 3.4mm Platform Min. 0.25 mm Max. N/A
C.) Gingival Margin Height 4.1mm/5mm/6mm External Hex /Certain Min. 0.25 mm Max. N/A
D.) Total Height Min. 4.75mm Max. 15.0mm
E.) Angulations Min. 0° Max. 30°
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
intra-oral optical scan or resin model scan
Anatomical Site
mandible or maxilla
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Validation performed on scanning equipment and software to ensure accuracy of scanning models to produce the intended design as cleared in K032263 & K052648.
Validation data demonstrates that the modified process results in a finished device that is just as safe and effective as Encode® Patient Specific Dental Abutments that are currently cleared under K032263 & K052648.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
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.(b)
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.)
0
K101607 - 510(k) Summary
MAR 1 1 2011
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92
Submitter:
BIOMET 3: 4555 Riverside Drive Palm Beach Gardens, FL 33410
Establishment Reg. Number: 1038806
Contact Person: Simeon Simone, Regulatory Affairs Specialist
Tel. 561-776-6831 Fax. 561-383-3407
Contact Phone/Fax/Email:
Email: simeon.simone@biomet.com
September 23th, 2010 Date Prepared:
Trade/Proprietary Name: Encode® Patient Specific Dental Abutments
Common/Usual Name: Dental Abutment
Root-form Endosseous Dental Abutment
Device Classification/Code: 872.3630
Predicate Device(s) :
Classification Name:
BIOMET 3i - Encode® Patient Specific Dental Abutments K032263 & K052648
Device Description:
Encode® Patient Specific Dental Abutments are designed specifically for a patient using a CAD/CAM system. The abutments are designed from a threedimensional intra-oral optical scan or resin model scan and then machined/milled according to the parameters created in a digital file which are derived from the scan. The abutments are manufactured from titanium alloy (Ti 6Al-4V ELI) or biocompatible Zirconia TZP. The abutment design is limited according to BIOMET 3i Specifications, as follows:
1
| Description | Min. | Max. |
|---|---|---|
| A.) Platform Seating Diameter | 3.4 mm | 6.0mm |
| B.) Gingival Margin Diameter | 3.8mm | 16.0mm |
| C.) Gingival Margin Height External | ||
| Hex 3.4mm Platform | 0.5 mm | N/A |
| C.) Gingival Margin Height Certain | ||
| 3.4mm Platform | 0.25 mm | N/A |
| C.) Gingival Margin Height | ||
| 4.1mm/5mm/6mm | ||
| External Hex /Certain | 0.25 mm | N/A |
| D.) Total Height | 4.75mm | 15.0mm |
| E.) Angulations | 0° | 30° |
Indications for Use:
Performance Data:
Equivalence Data:
Encode® Patient Specific Dental Abutments made from oral scans provided from Sirona CEREC AC Scanner System and inLab Software v3.65 are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. Encode® Patient Specific Dental Abutments 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.
Encode® Patient Specific Dental Abutments made from oral scans provided from Sirona CEREC AC Scanner System and inLab Software v3.65 have the same intended use and indications, principles of operation, and technological characteristics as previously cleared Encode® Patient Specific Dental BIOMET 3i Abutments. The additional option of oral scans as a source of digital images for existing design CAD/CAM do not raise any new questions of safety or software effectiveness. Validation data demonstrates that the modified process results in a finished device that is just as safe and effective as Encode® Patient Specific Dental Abutments that are currently cleared under K032263 & K052648. Thus, the Encode® Patient Specific Dental Abutments are substantially equivalent to its predicate devices.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal 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 Cabrera Senior Manager - Regulatory Affairs BIOMET 3i 4555 Riverside Drive Palm Beach Gardens, Florida 33410
MAR 1 1 201
Re: K101607
Trade/Device Name: Encode® Patient Specific Dental Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: February 24, 2011 Received: February 28, 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 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.ida.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/Industry/default.htm.
Sincerely yours.
Anthony D. Watson
Anthony B. 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): K101607
Device Name:
Encode® Patient Specific Dental Abutments
Indications for Use:
Encode® Patient Specific Dental Abutments made from oral scans provided from Sirona CEREC AC Scanner System and inLab Software v3.65 are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. Encode® Patient Specific Dental Abutments 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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Penny
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control and Dental Devices
510(k) Number: 3