(350 days)
No
The 510(k) summary describes a mechanical dental abutment and its compatibility and mechanical testing, with no mention of AI or ML.
No
Explanation: A therapeutic device is designed to treat or alleviate a medical condition. This device, a dental abutment, is a support for prostheses and does not directly treat a disease or medical condition. It's a restorative component, not a therapeutic one.
No
This device, a dental abutment, is intended to support dental prostheses, not to diagnose medical conditions or analyze patient data.
No
The device description explicitly states that the device is a titanium abutment, which is a physical hardware component. The summary also details mechanical testing and biocompatibility testing, which are relevant to hardware devices, not software-only devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a dental abutment used as a support for tooth prostheses in the mouth (maxilla or mandible). This is a physical device used in a surgical/restorative procedure.
- Device Description: The description details a titanium abutment and screw, again describing a physical component for dental restoration.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically reagents, instruments, or systems used for testing biological samples.
The information provided describes a medical device used in a dental procedure, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
Denracle Dental Abutment for Osstem GS Implant is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
This device is compatible with the following implant system: OSSTEM GS Fixture System Ø 4.0 mm, Ø 4.5 mm and Ø 5.0 mm.
Product codes
NHA
Device Description
Denracle Dental Abutment for Osstem GS Implant are titanium abutments designed to be used in conjunction with specific dental implants utilizing the Dental Abutment screw, which is made of Ti-6A1-4V ELI titanium and is used to secure the abutment to the implant. In combination with the implant, the abutments support single or multi-unit cement-retained restorations in the maxillary and/or mandibular arch. Denracle Dental Abutment for Osstem GS Implant is compatible with the following implant systems: OSSTEM GS Fixture System 04.0 mm, Ø4,5 and Ø5,0mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxilla or mandible
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)
Mechanical testing, according to ISO 14801 Dentistry - Fatigue test for endosseous dental implants, was conducted on a worst-case scenario to ensure that the strength Denral Abutment for Osstem GS Implant is appropriate for its intended use.
Compatibility testing was conducted on the abutments and corresponding dental implants (which have had previous 510(K) clearance in K072896) with designated screws, the dimensions, tolerances and rotation parameters were evaluated in determining appropriate fit.
Biocompatibility testing and sterilization was performed on the device with acceptable results.
These testing results show that Denracle Dental Abutment for Osstem GS Implant made of titanium, for their respective dental implant system have sufficient mechanical strength for their intended clinical application and are compatible with the implant system for which they are indicated for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
reen DenTech Co., Ltd
2F. No. 17, Deyuanpi Blvd., Da Nong Li, Liouying District, Tainan City, 73659, Taiwan.
MAY 0 6 2014
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is prepared in accordance with the requirements of SMDA 1990 and 21 CFR 807.92 on May 06, 2014.
The assigned 510(k) number is: K131468
1. APPLICANT's NAME AND ADDRESS
| Applicant' Name: | Green DenTech Co., Ltd |
|---|---|
| Address: | 2F, No. 17, Deyuanpi Blvd., Da Nong Li, |
| Liouying District, Tainan City, 73659, | |
| Taiwan. | |
| Telephone: | 886-6-6230999 |
| Fax: | 886-6-6230789 |
| Official contact: | Henry H.J. Shih |
| Date Prepared: | May 06, 2014 |
2. DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | Denracle Dental Abutment |
|---|---|
| Common Name: | Dental implant abutment |
| Classification Regulations: | Endosseous dental implant abutment |
| Class II, 21 CFR 872.3630 | |
| Product Code: | NHA |
| Classification Panel: | Dental Products Panel |
| Reviewing Branch: | Dental Devices |
3. LEGALLY MARKETED DEVICES TDS Abutment for Friadent Xive - K103339.
4. DEVICE DESCRIPTION
Denracle Dental Abutment for Osstem GS Implant are titanium abutments designed to be used in conjunction with specific dental implants utilizing the Dental Abutment screw, which is made of Ti-6A1-4V ELI titanium and is used to secure the abutment to the implant. In combination with the implant, the abutments support single or multi-unit cement-retained restorations in the maxillary and/or mandibular arch. Denracle Dental Abutment for Osstem GS Implant is compatible with the following implant systems: OSSTEM GS Fixture System 04.0 mm, Ø4,5 and Ø5,0mm.
INTENDED USE OF THE DEVICE 5.
Denracle Dental Abutment for Osstem GS Implant is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
This device is compatible with the following implant system: OSSTEM GS Fixture System 0 4.0 mm, Ø 4.5 mm and Ø 5.0 mm.
1
T Green DenTech Co., Ltd
2F, No. 17, Deyuanpi Blvd., Da Nong Li, Liouying District, Tainan City, 73659, Taiwan.
6. TECHNOLOGICAL CHARACTERISTICS
Denracle Dental Abutment for Osstem GS Implant has the following similarities to the predicate devices, TDS Abutment for Friadent Xive, which have been determined by FDA:
- · Has the same intended use,
- . Use the same operating principle,
- . Incorporates the same basic design,
- . Incorporates the same materials, and
- Is produced using the same processes.
The basis for Green DenTech Co., Ltd. Belief that TDS Abutment for Friadent Xive is substantially equivalent to the predicate devices is summarized in the following table.
| Predicate Devices | Subject Device | |
|---|---|---|
| Denracle Dental Abutment for | Pou Yu Biotechnology Co. | |
| Osstem GS implant | TDS Abutment for Friadent Xive | |
| K103339 | ||
| Intended use | Denracle Dental Abutment for | |
| Osstem GS Implant is intended for | ||
| use with dental implants as a | ||
| support for single or multiple tooth | ||
| prostheses in the maxilla or | ||
| mandible of a partially or fully | ||
| edentulous patient. |
Denracle Dental Abutment for
Osstem GS Implant is compatible
with the following implant system:
OSSTEM GS Fixture System Ø 4.0
mm, Ø 4.5 mm and Ø 5.0 mm. | TDS Abutment for Friadent Xive is
intended for use with dental
implants as a support for single or
multiple tooth prostheses in the
maxilla or mandible of a partially or
fully edentulous patient.
TDS Abutment for Friadent Xive is
compatible with the following
implant systems which have an
internal hex 1.78mm or greater:
Firadent: FRIALIT Implant, Xive
Implant; 3i: Internal connect Type;
Astra: Osseospeed Implant,
Osseospeed TX Implant;
BioHorizons: Internal Implant
system, Tapered Internal Implant
System, Single-Stange Implant
System, Laser-lok 3.0 implant
RENOVA ™ Internal Hex Implant
System; Zimmer: Tapered
Screw-Vent Implant System,
Screw-Vent Implant System,
AdVent Implant System; Osstem:
GS system; Noble Biocare: Active
Impalnt. |
| Custom Design | | |
| Attachment | Implant level | Implant level |
| Restoration | Cement-retained | Cement-retained |
| CAD/CAM
processing | Not CAD/CAM millable | Yes |
| Material | | |
| Abutment | Ti-6A1-4V ELI | Ti-6A1-4V ELI
Y-TZP Zinconia |
| Screw | Provided by Green Dentech Co.,
Ltd. | Provided by Pou Yu Biotechnology
Co. Ltd |
2
reen DenTech Co., Ltd
2F, No. 17, Deyuanpi Blvd., Da Nong Li, Liouying District, Tainan City, 73659, Taiwan.
7. NON-CLINICAL TESTING DATA
Mechanical testing, according to ISO 14801 Dentistry - Fatigue test for endosseous dental implants, was conducted on a worst-case scenario to ensure that the strength Denral Abutment for Osstem GS Implant is appropriate for its intended use.
Compatibility testing was conducted on the abutments and corresponding dental implants (which have had previous 510(K) clearance in K072896) with designated screws, the dimensions, tolerances and rotation parameters were evaluated in determining appropriate fit.
Biocompatibility testing and sterilization was performed on the device with acceptable results.
These testing results show that Denracle Dental Abutment for Osstem GS Implant made of titanium, for their respective dental implant system have sufficient mechanical strength for their intended clinical application and are compatible with the implant system for which they are indicated for use.
8. CONCLUSION
Green DenTech Co., Ltd demonstrated that, for the purposes of FDA's regulation of medical devices, GO series Dental Abutment for Osstem GS Implant is substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA".
Public Health Service
Food and Drug Administration 10903 New Harnoshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 6, 2014
Green DenTech Company Limited Ms. Sue Ru Official Correspondent 2F, No. 17. Deyuanpi Boulevard Danung Li, Liouying District Tainan 73659 TAIWAN
Re: K131468
Trade/Device Name: Denracle Dental Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: February 13, 2014 Received: March 24, 2014
Dear Ms. Ru:
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. Ru
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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,
MarySBunner-S
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
Indications for Use
510(k) Number (if known) K131468
Device Name Denracle Dental abutment
Indications for Use (Describe)
manage Dental Abument for OSSTEM GS Implant is intended for use with dental implant as a support for single or multiple tooth prosthoses in maxilla or mandible of a partially or fully edentulous patient. This device is compatible with the following implant system:OSSTEM GS Fixture System 04.0mm > 04.5mm > 05.0mm •
Type of Use (Select one or both, as epplicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995. •DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of Information Is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chlef Information Officer Paparwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of Information unless it displays a currently valid OMB number."
FORM FDA 3881 (1/14)
PJC Tablinkang Sermans (J0 | ) 443-4740
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K131468
.
Device Name Denracle Dental abutment
Indications for Use (Describe)
morale Dental Abutunent for OSSTEM GS implant is intended for use with destablimplant as a support for single or multiple tooth prostheses in maxilla or mandible of a partially or fully edentulous patient. This device is compatible with the following implant system:OSSTEM GS Fixture System 64.0mm > ø4.5mm > ø5.0mm •
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------- |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | Sheena A. Green -S |
|---|---|
| 2014.05.06 12:54:45 | |
| -04'00' |
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 78 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (1/14)
Page 1 of 1
PIC Publica: Bertuu (201) 417-674)