(140 days)
K62030, K101096
No
The device description and intended use are purely mechanical, and there is no mention of AI/ML terms or data processing that would suggest AI/ML is involved.
No
The device aids in prosthetic restoration by supporting dental prosthetics; it is not described as directly treating or preventing disease.
No.
The "Intended Use" clearly states that the device is "intended for use with a dental implant to provide support for prosthetic restorations." It is a structural component for dental reconstruction, not a tool for diagnosis.
No
The device description clearly states it is a physical device made of titanium alloy, intended for use as a dental implant abutment. It is a hardware component.
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 for providing support for prosthetic restorations in dental implants. This is a mechanical function within the body.
- Device Description: The description details a physical component made of titanium alloy used in dental procedures.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Anatomical Site: The anatomical site is dental (anterior and posterior), which is a physical location within the body, not a specimen source.
IVD devices are used to perform tests on samples taken from the body (like blood, urine, tissue) to diagnose or monitor medical conditions. This device is a physical component used in a surgical/restorative procedure.
N/A
Intended Use / Indications for Use
The Multi Angled Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as bridges, or overdentures.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The Multi Angled Abutment is device made of titanium alloy intended for use as an aid in prosthetic restoration. The Multi Angled Abutment is used with Esthetic -low Cylinders (only Non-Hex) in the US System. K62030 and connected to HTIII SA Fixture in the HT3 SA Fixture System, K101096.
- The Multi Angled Abutment consists of Abutment and Abutment Screw.
- The Multi angle Abutment is used to elevate restoration platform when restoration to implant level is not practical due to depth or angle of implant for the edentulous patients in Anterior and Posterior, not customizable and can't be use a single product
- The Multi Angled Abutment is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.
- The Multi Angled Abutment is substantially equivalent in design, function and intended use to Prosthetic System (K110308) of OSSTEM Implant Co., Ltd.,
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
No clinical studies are submitted. Safety tests including biocompatibility have been considered to ensure the devices comply with the applicable international and US regulations. The Multi Angled Abutment is made of the same materials, manufacturing process, chemical composition, body contact with the predicate devices, Prosthetic System, OSSTEM Implant Co., Ltd., K110308 also, Risk analysis and dimension inspection were conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K12-3755
SSTEM Implant Co., Lt 507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea
el: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
510(k) Summary
APR 2 6 2013
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: November 30, 2012
- Company and Correspondent making the submission:
-
Submitter's Name :
-
Address :
-
Contact :
-
Phone:
-
Correspondent's Name:
-
Address:
-
Contact:
-
Phone:
-
- Device :
Trade or (Proprietary) Name : Common or usual name :
Classification Name :
OSSTEM Implant Co., Ltd. #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804, Republic of Korea Mr. Hee Kwon Son +82 51 850 2575
HIOSSEN Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 Patrick Lim 888 678 0001
Multi Angled Abutment Dental Abutment Abutment, implant, dental, endosseous 21CFR872.3630 Class II NHA
-
- Predicate Device :
Prosthetic System, OSSTEM Implant Co., Ltd., K110308
- Predicate Device :
4. Description :
The Multi Angled Abutment is device made of titanium alloy intended for use as an aid in prosthetic restoration.
. ·
The Multi Angled Abutment is used with Esthetic -low Cylinders (only Non-Hex) in the US System. K62030 and connected to HTIII SA Fixture in the HT3 SA Fixture System, K101096
- The Multi Angled Abutment consists of Abutment and Abutment Screw.
QS-Q1-505-3(Rev.0)
Letter(8.5 X 11in)
1
-
- The Multi angle Abutment is used to elevate restoration platform when restoration to implant level is not practical due to depth or angle of implant for the edentulous patients in Anterior and Posterior, not customizable and can't be use a single product
-
- The Multi Angled Abutment is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.
-
- The Multi Angled Abutment is substantially equivalent in design, function and intended use to Prosthetic System (K110308) of OSSTEM Implant Co., Ltd.,
| Multi Angled Abutment | Prosthetic System | |
|---|---|---|
| Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd |
| 510(k) Number | New | K110308 |
| Design | Image: Multi Angled Abutment design | Image: Prosthetic System design |
| Image: Multi Angled Abutment design details prevent exposure of the screw hole and form the natural gingival shape | Image: Prosthetic System design details | |
| Intended use | Multi Angled Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. | Prosthetic System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. |
- Substantial Equivalence Matrix
2
OSSTEM
IMPLANT
STEM Impla
07-8 Geoje3-Dong Yeonje-Gu Busan, 611 el: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
| Dimension | ||
|---|---|---|
| A( $°$ ) | 17, 30 | 17, 30 |
| B(mm) | 3.17, 3.4, 4.17, 4.4, 4.76, 4.86, | |
| 5.17, 5.4, 5.76, 5.86, 6.76, 6.86 | 5, 5.1, 5.5, 5.6, 6, 6.1, 6.5, 6.6, 7.5, | |
| 7.6 | ||
| C( $Ø$ ) | 2.88, 3.43 | 2.84, 2.88, 3.39, 3.43 |
| D( $Ø$ ) | 4.8 | 4.9 |
| Connection | There is no modification to the abutment/implant connect has been made. | |
| Therefore, There is no difference in connection part when compare with | ||
| predicate device(K110308) |
-
- Indication for use :
The Multi Angled Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as bridges, or overdentures.
- Indication for use :
-
- Review :
The Multi Angled Abutment has similar material, indication for use, design and technological characteristics as the predicate device.
- Review :
7. Summary of nonclinical testing
Safety tests including biocompatibility have been considered to ensure the devices comply with the applicable international and US regulations as below.
The Multi Angled Abutment is made of the same materials, manufacturing process, chemical composition, body contact with the predicate devices, Prosthetic System, OSSTEM Implant Co., Ltd., K110308 also, Risk analysis and dimension inspection were conducted
-
- Summary of clinical testing No clinical studies are submitted
-
- Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based
QS-QI-505-3(Rev.0)
Letter(8.5 X 11in)
3
Image /page/3/Picture/0 description: The image shows the word "OSSTEM" in a stylized font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller font. The letters are black and the background is white. There is a degree symbol after the word "OSSTEM".
OSSTEM Implant Co., Ltd. #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
on the information provided in this premarket notification Osstem Implant Co., Ltd. concludes that the Multi Angled Abutment is substantially equivalent to the predicate devices as .. described herein.
QS-QI-505-3(Rev.0)
4
Image /page/4/Picture/1 description: The image shows the 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. Inside the circle is a stylized symbol that resembles a person with outstretched arms, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 26, 2013
OSSTEM Implant Company, Limited C/O Mr. Patrick Lim HIOSSEN, Incorporated 85 Ben Fairless Drive FAIRLESS HILL PA-19030
Re: K123755
Trade/Device Name: Multi Angled Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: March 13, 2013 -Received: March 27, 2013
Dear Mr. Lim:
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.
5
Page 2 - Mr. Lim
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 devicerelated 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/ResourcesforYou/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/5/Figure/8 description: The image shows a signature and a digitally signed statement. The signature reads "Susan Runner, DDSMA". The digitally signed statement indicates that the document was signed by Mary S. Runner-S on April 26, 2013, at 11:24:11 -04'00'. The statement also includes details such as DN, organizational units (HHS, FDA, People), and a numerical identifier.
for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
OSSTEM Implant C
OSSTEM® #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.co
Indications for Use
K123755 510(k) Number K
Device Name : Multi Angled Abutment
Indication for use : Multi Angled Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as bridges, or overdentures.
Prescription Use_ ਮ (Per 21CFR801 Subpart D) OR Over-The-Counter Use (Per 21CFR807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Digitally signed by Mary S. Runner | |
|---|---|
| DN: c=US, o=U.S. Government, | |
| ou=HHS, ou=FDA, ou=People, | |
| cn=Mary S. Runner S, | |
| 0.9.2342:19200300.100.1.1=13000 | |
| 87950 | |
| Date: 2013.04.26 11:21:11 -04'00' |
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K123755 |
|---|---|
| ---------------- | --------- |
QS-QI-505-2(Rev.0)
Letter(8.5 X 1 im)
. [ .