(164 days)
No
The summary describes a metal dental device for stabilizing bone grafts and makes no mention of AI or ML technology.
No
The device is described as a non-resorbable metal membrane intended to stabilize and support bone graft in dento-alveolar bony defect sites, which aligns with device functionalities rather than direct therapeutic action.
No
The device description clearly states its purpose is to "stabilize and support of bone graft in dento-alveolar bony defect sites," which is a treatment function, not a diagnostic one.
No
The device description explicitly states it is a "metal (Non-resorbable membrane) device" and describes physical components like "SB Anchor" and its connection to "Healing abutment or Cover Cap," indicating it is a hardware 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 the device is a "metal (Non-resorbable membrane) device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites." This describes a surgical implant used directly in the body for structural support, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The description details a physical component ("SB Anchor") used in conjunction with dental implants and other dental devices. This aligns with a medical device used in a surgical procedure, not an IVD.
- 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, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening
Therefore, the SMARTbuilder System, as described, is a medical device used in dental surgery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
SMARTbuilder System is a metal (Non-resorbable membrane) device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
SB Anchor is used for connecting with Healing abutment or Cover Cap on the top of the SB Anchor to fix the SMARTbuilder that is predicated 510(K), K120951, K130840
The SB Anchor has the same material, indication for use, technological characteristics and similar design as the predicate device, Height in the SMARTbuilder System
The SB Anchor is designed for use with NT Fixture connection (K081078) and TS SA Fixture connection (K121995)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dento-alveolar bony defect sites.
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)
Summary of nonclinical testing
Biocompatibility evaluation for SB Anchor is not considered because material of SB Anchor is same with Height of SMARTbuilder System(K120951)
Summary of clinical testing No clinical studies are submitted
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.
SMARTbuilder System, OSSTEM IMPLANT CO.,LTD (K120951)
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.
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.)
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Auqust 21, 2014
OSSTEM Implant Company, Limited C/O Mr. Patrick Lim Manager HIOSSEN Incorporated 85 Ben Fairless Drive Fairless Hills, PA 19030
Re: K140600
Trade/Device Name: SB Anchor Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 23, 2014 Received: July 10, 2014
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.
1
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 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,
Mary S. Runner -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/1 description: The image shows the logo and contact information for OSSTEM Implant Co., Ltd. The logo includes the company name in a bold, sans-serif font, with the word "OSSTEM" in a larger font size than "Implant Co., Ltd." The address is listed as 203, Geoje-daero, Yeonje-Gu Busan, 611-804 Republic of Korea. The telephone number is +82 51 850-2500, the fax number is +82 51 850-4341, and the website address is www.osstem.com.
Indications for Use Statement
Indications for Use
140600 510(k) Number K
Device Name : SB Anchor
Indication for use : SMARTbuilder System is a metal (Non-resorbable membrane) device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites.
Prescription Use X (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)
QS-QI-505-2(Rev.0)
Letter(8.5 X 11in)
3
Image /page/3/Picture/1 description: The image shows the logo and contact information for OSSTEM Implant Co., Ltd. The logo includes the company name in bold, black font, with the word "OSSTEM" also appearing in orange next to the company name. The contact information includes the address, phone number, fax number, and website.
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: February 21, 2014
- Company and Correspondent making the submission:
| - Submitter's Name : | OSSTEM Implant Co., Ltd. |
|---|---|
| - Address : | 203, Geoje-daero, Yeonje-Gu |
| Busan, 611-804, Republic of Korea | |
| - Contact : | Mr. Hee Kwon Son |
| - Phone: | +82 51 850 2575 |
| - Correspondent's Name: | HIOSSEN Inc. |
| - Address: | 85 Ben Fairless Dr. Fairless Hills, PA 19030 |
| - Contact: | Patrick Lim |
| - Phone: | 888 678 0001 |
| 2. Device : |
| Trade or (Proprietary) Name : | SB Anchor |
|---|---|
| Common or usual name : | Dental Abutment |
| Classification Name : | Endosseous dental implant abutment |
| 21CFR872.3630 | |
| Class II | |
| NHA |
-
- Predicate Device :
SMARTbuilder System, OSSTEM IMPLANT CO.,LTD (K120951)
- Predicate Device :
The SB Anchor has the same material, indication for use, technological characteristics and similar design as the predicate device, Height in the SMARTbuilder System
The SB Anchor is designed for use with NT Fixture connection (K081078) and TS SA Fixture connection (K121995)
QS-QI-505-3(Rev.0)
Letter(8.5 X 11in)
4
Image /page/4/Picture/0 description: The image shows the logo for Osstem Implant. The logo is orange and black. The word "OSSTEM" is in orange, and the word "IMPLANT" is in black. The logo is simple and modern.
OSSTEM Implant Co., Ltd.
203, Geoje-daero, Yeonje-Gu Busan, 611-804 Republic of Korea
Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
| Material | Titanium alloy Ti-6Al-4V
(ASTM F 136) | Compatible connection /
Dimension | NT Fixture
Connection
TS SA Fixture
Connection | Diameter : 3.5, 4.0, 5.0
Length: 6.35 ~ 9.85
Diameter : 3.3, 3.7, 4.2,
4.25, 4.4, 4.6, 4.63, 4.65,
4.9, 5.05, 5.08, 5.1
Length: 7.0~15 |
|--------------------|------------------------------------------|--------------------------------------|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| surface treatments | none | Method of Sterilization | | Radiation (Gamma) |
- Substantial Equivalence Matrix
| | SB Anchor | SMARTbuilder System
Height | |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | Proposed | K120951 | |
| Manufac
turer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Design | Image: SB Anchor Design | Image: SB Anchor Design | Image: SMARTbuilder System Height Design |
| Compatible
Fixture | NT Fixture (K081078) | TS SA Fixture (K121995) | GS III System (K091208) |
| Indication
for use | SMARTbuilder System is a
metal (Non-resorbable
membrane) device
intended for use with a dental
implant to stabilize and
support of bone graft in dento-
alveolar bony defect sites. | SMARTbuilder System is a
metal (Non-resorbable
membrane) device
intended for use with a dental
implant to stabilize and support
of bone graft in dento-alveolar
bony defect sites. | SMARTbuilder is a metal
device intended for use with a
dental implant to stabilize and
support of bone graft in dento-
alveolar bony defect sites. |
| Material | Titanium alloy Ti-6Al-4V
(ASTM F 136) | Titanium alloy Ti-6Al-4V
(ASTM F 136) | Titanium alloy Ti-6Al-4V
(ASTM F 136) |
| Dimension | Diameter : 3.5, 4.0, 5.0
Length: 6.35 ~ 9.85 | Diameter : 3.3, 3.7, 4.2, 4.25,
4.4, 4.6, 4.63, 4.65, 4.9, 5.05,
5.08, 5.1
Length: 7.0~ 15 | Diameter : 3.3, 4
Length: 7.15 ~ 9.85 |
| surface
treatments | None | None | None |
| Sterilization | Sterile | Sterile | Sterile |
| Shelf life | 8years | 8years | 8years |
| SE | The SB Anchor has the same material, indication for use, technological characteristics and similar
design as the predicate device, Height in the SMARTbuilder System
Product name is changed SMARTbuilder System, Height to SB Anchor and addition various
anchor shape products to apply various connection structure | | |
QS-QI-505-3(Rev.0)
Letter(8.5 X 11in)
5
Image /page/5/Picture/1 description: The image shows the logo for Osstem Implant. The logo is orange and gray. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray and is located below the word "OSSTEM."
DSSTEM Implant Co., Ltd.
03, Geoje-daero, Yeonje-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
-
- Indication for use
SMARTbuilder System is a metal (Non-resorbable membrane) device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites.
- Indication for use
-
- Review :
The SB Anchor has the same material, intended for use and technological characteristics as the predicate device.
- Review :
-
- Summary of nonclinical testing
Biocompatibility evaluation for SB Anchor is not considered because material of SB Anchor is same with Height of SMARTbuilder System(K120951)
- Summary of nonclinical testing
-
- 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 on the information provided in this premarket notification Osstem Implant Co., Ltd. concludes that the SB Anchor is substantially equivalent to the predicate devices as described herein.