(276 days)
No
The description focuses on CAD/CAM design and machining based on digital scans and predefined parameters, with no mention of AI or ML algorithms for design or analysis.
Yes
The device is described as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient, which by definition performs a therapeutic function.
No
Explanation: The device is an accessory to dental implants intended to support prosthetic devices. It is used for design and manufacturing, not for diagnosing medical conditions.
No
The device description clearly states that the device is a physical dental abutment manufactured from titanium alloy or zirconia, which is a hardware component. While software is used in the design process, the final product is not software-only.
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 device is an accessory to dental implants to support a prosthetic device in a patient. This is a direct clinical application within the body, not a test performed in vitro (outside the body) on biological specimens to diagnose a condition.
- Device Description: The description details a physical dental abutment designed and manufactured for a patient based on scans. It's a physical implant component, not a reagent, instrument, or system used for diagnostic testing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue), detecting biomarkers, or providing diagnostic information about a patient's health status.
The device is a medical device used in dentistry for restorative purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Encode® Patient Specific Dental Abutments made from oral scans provided from 3M ESPE Lava Chair Scanner and the 3M Lava COS (2.0) software 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
872.3630, NHA
Device Description
Patient Specific Dental Abutments are Encode® 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
Validation performed on scanning equipment and software to ensure accuracy of scanning models to produce the intended design as cleared in K032263 & K052648.
Key Metrics
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.)
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MAR 1 1 2011
K101608 - 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92
| Submitter: | BIOMET 3i 4555 Riverside Drive Palm Beach Gardens, FL 33410 |
|---|---|
| ------------ | ------------------------------------------------------------- |
Establishment Reg. Number: 1038806
Juliana Arias, Regulatory Affairs Specialist Contact Person:
Contact Phone/Fax/Email:
Fax. 561-514-6316 Email: Juliana.Arias@biomet.com
Tel. 561-776-6999 ext.7208
September 28th, 2010 Date Prepared:
Trade/Proprietary Name: Encode® Patient Specific Dental Abutments
Dental Abutment Common/Usual Name:
Root-form Endosseous Dental Abutment
872.3630 Device Classification/Code:
Predicate Device(s) :
Classification Name:
Device Description:
BIOMET 3i - Encode® Patient Specific Dental Abutments K032263 & K052648
Patient Specific Dental Abutments are Encode® 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 3M ESPE Lava Chair Scanner and the 3M Lava COS (2.0) software 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 3M ESPE Lava Chair Scanner and the 3M Lava COS (2.0) software 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 software do not raise any new questions of safety or 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/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol of medicine and health. The caduceus is composed of three wavy lines, representing the three branches of government: executive, legislative, and judicial.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Juliana Arias Regulatory Affairs Specialist BIOMET 3i 4555 Riverside Drive Palm Beach Gardens, Florida 33410
MAR 1 1 2011
Re: K101608
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 Ms. Arias:
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- Ms. Arias
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/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): K101608
Device Name:
Encode® Patient Specific Dental Abutments
Indications for Use:
Encode® Patient Specific Dental Abutments made from oral scans provided from 3M ESPE Lava Chair Scanner and the 3M Lava COS (2.0) software 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.
X Prescription Use (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)
| Susa Kayer | |
|---|---|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital |
Division of Hematology/Oncology
Infection Control, Dental Services
510(K) Number: F101608