(246 days)
Unknown
The input imaging modality mentions "Sirona CEREC AI", which could potentially indicate the use of AI in the scanning process, but the rest of the document does not provide further details or confirmation of AI/ML technology within the device itself or its software.
No
The device, the Link Abutment for CEREC, is an abutment for dental implants, providing support for prosthetic restorations. It is a structural component for dental reconstruction, not a device used to treat or cure a disease or medical condition.
No
Explanation: The device is an abutment for dental implants used to support prosthetic restorations. Its function is mechanical and structural support, not the diagnosis of a condition or disease. While it interfaces with scanning technology, that technology is for design and manufacturing, not diagnosis.
No
The device description explicitly states the device is a pre-manufactured (stock) abutment made from a titanium alloy, which is a physical hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide support for customized prosthetic restorations on dental implants. This is a mechanical function within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical abutment made of titanium alloy, designed to interface with dental implants and CAD/CAM systems for creating dental prosthetics. It does not involve any reagents, assays, or analysis of biological samples.
- 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 specific substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly a dental prosthetic component used in the process of restoring teeth, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Link Abutment for CEREC is titanium alloy abutments placed onto HIOSSEN dental implants to provide support for customized prosthetic restorations. Link Abutment for CEREC is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.
• Link abutment for CEREC
All digitally designed copings and/or crowns for use with the Link abutment for CEREC is to be scanned using Sirona CEREC AC or CEREC AF or CEREC AI, designed using Sirona inLab software (Version 3.65) or Sirona CEREC Software (Version 4.2) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. CAD/CAM manufacturing/milling occurs at dental laboratories per the design limitations of the Sirona CEREC.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The Link Abutment for CEREC provide the interface for mesostructure designed and milled using the Sirona CEREC system with HIOSSEN Implant System (K140934) The Link Abutment for CEREC is pre-manufactured (stock) abutment made from a titanium alloy (ASTM F 136). The Link Abutment for Cerec is a Ti-base abutment design consisting of the Link Abutment and Sirona ceramic mesostructure. The coronal portion is designed to interface with the pre-machined mounting hole in the milling blanks compatible with the Sirona CEREC MC X and MC XL prosthetic milling systems.
The Link Abutment for CEREC & superstructure must be sterilized in an autoclave (gravity displacement) at 132°C for 15 minutes before use. After the steam sterilization, the abutments & superstructure should be dried for 15 minutes before use.
Link Abutment for CEREC Material: Titanium Alloy (Ti-6Al-4V)
Gingival heights: 0.5mm
type of connection: 11° Morse taper internal connection, Mini Connection Hex, Non-Hex, Regular Connection Hex, Non-Hex
Diameter: Ø 4.5mm
Post Height: 4.7mm
Mentions image processing
Not Found
Mentions AI, DNN, or ML
All digitally designed copings and/or crowns for use with the Link abutment for CEREC is to be scanned using Sirona CEREC AC or CEREC AF or CEREC AI, designed using Sirona inLab software (Version 3.65) or Sirona CEREC Software (Version 4.2) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.
Input Imaging Modality
Scanned using Sirona CEREC AC or CEREC AF or CEREC AI
Anatomical Site
HIOSSEN dental implants, partially or fully edentulous mandibles and maxillae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental laboratories
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)
Fatigue testing was considered according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" with the worst case scenario. Sterilization was conducted according to ISO 17665-1:2006. Biocompatibility for the Link Abutment Tibase component is demonstrated by the reference to K120847. All non-clinical testing was conducted for the subject device. 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.
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.)
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, often associated with medicine and healthcare. The logo is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 28, 2016
OSSTEM Implant Co., Ltd % David Kim Manager HiOSSEN Inc. 85 Ben Fairless Dr. Fairless Hills, Pennsylvania 19030
Re: K160519
Trade/Device Name: Link Abutment for CEREC Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: September 28, 2016 Received: September 28, 2016
Dear David Kim:
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.
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
1
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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
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 large, bold font, with the word "OSSTEM" in orange and "Implant Co., Ltd." in black. Below the logo is the company's address: 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea. The image also includes the company's telephone number (+82 51 850-2500), fax number (+82 51 850-4341), and website address (www.osstem.com).
Indications for Use Statement
510(k) Number: K160519
Device Name : Link Abutment for CEREC
Indication for use :
The Link Abutment for CEREC is titanium alloy abutments placed onto HIOSSEN dental implants to provide support for customized prosthetic restorations. Link Abutment for CEREC is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.
• Link abutment for CEREC
All digitally designed copings and/or crowns for use with the Link abutment for CEREC is to be scanned using Sirona CEREC AC or CEREC AF or CEREC AI, designed using Sirona inLab software (Version 3.65) or Sirona CEREC Software (Version 4.2) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. CAD/CAM manufacturing/milling occurs at dental laboratories per the design limitations of the Sirona CEREC.
Prescription Use X OR (Per 21CFR801 Subpart D)
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)
3
DSSTEM Implant Co., Ltd.
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
510(k) Summary
Date: October 28, 2016
| - Submitter's Name: | OSSTEM Implant Co., Ltd. |
|---|---|
| - Address : | 66-16, Bansong-ro 513beon-gil, Haeundae-gu, |
| Busan, 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: | DAVID KIM |
| - Phone: | 267 759 7031 |
| Device: | |
| Trade or (Proprietary) Name : | Link Abutment for CEREC |
| Common or usual name : | Dental Abutment |
| Classification Name : | Endosseous dental implant abutment |
| 21CFR872.3630 | |
| Class II | |
| NHA |
3. Predicate Device(s):
Primary Predicate(s)
-
· ET/SS IMPLANT SYSTEM, OSSTEM IMPLANT CO.,LTD. K120847
Reference Predicate(s) -
Straumann® Variobase® for CEREC®, Abutment Models RN, WN, ● RC, NC, Straumann USA, LLC, - K151324
-
· Sirona Dental Systems GmbH, Sirona Dental CAD/CAM System cleared under K11421;
-
Sirona Dental Systems GmbH, Sirona Dental CAD/CAM System cleared under K100152;
-
- Description:
The Link Abutment for CEREC provide the interface for mesostructure designed and milled using the Sirona CEREC system with HIOSSEN Implant System (K140934) The Link Abutment for CEREC is pre-manufactured (stock) abutment made from a titanium alloy (ASTM F 136). The Link Abutment for Cerec is a Ti-base abutment design consisting of the Link Abutment and Sirona ceramic mesostructure. The coronal portion is designed to interface with the pre-machined mounting hole in the milling blanks compatible with the Sirona CEREC MC X and MC XL prosthetic milling systems
4
Image /page/4/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. The logo is simple and modern.
OSSTEM Implant Co., Ltd.
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
The Link Abutment for CEREC & superstructure must be sterilized in an autoclave (gravity displacement) at 132°C for 15 minutes before use. After the steam sterilization, the abutments & superstructure should be dried for 15 minutes before use.
Design limitation for Superstructure
| (Unit: mm) | |||
|---|---|---|---|
| Superstructure design limitation | |||
| Range | |||
| (Diameter) | Range | ||
| (Height) | Range | ||
| (Wall thickness) | Range | ||
| (Angle) | |||
| 4.2~15 | 6~15 | Min. 0.275 | 0~20° |
| Item | Content | |
|---|---|---|
| Link Abutment for | ||
| CEREC | Material | Titanium Alloy (Ti-6Al-4V) |
| Gingival | ||
| heights | 0.5mm | |
| type of | ||
| connection | 11° Morse taper internal connection | |
| Mini Connection Hex, Non-Hex | ||
| Regular Connection Hex, Non-Hex | ||
| Diameter | $Ø$ 4.5mm | |
| Post Height | 4.7mm |
- Substantial Equivalence Matrix
| Part Name | Link Abutment for
CEREC | Primary Predicate | Reference predicate |
|--------------|-----------------------------|-----------------------------|-----------------------------------------------------|
| | | Transfer Abutment | Straumann Variobase
for CEREC |
| 510K | K160519 | K120847 | K151324 |
| Material | Titanium Alloy | Titanium Alloy | Titanium-Aluminum-
Niobium
alloy (Ti-6Al-7Nb) |
| Manufacturer | OSSTEM Implant Co.,
Ltd. | OSSTEM Implant Co.,
Ltd. | Institut Straumann AG |
5
Image /page/5/Picture/0 description: The image shows the text 'K160519' in a simple, sans-serif font. The text is black and appears to be on a white background. The characters are evenly spaced and clearly legible.
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. There is a small superscripted "a" in the upper right corner of the logo.
OSSTEM Implant Co., Ltd.
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
| Indication for use | The Link Abutment for CEREC is titanium alloy abutments placed onto HIOSSEN dental implants to provide support for customized prosthetic restorations. Link Abutment for CEREC is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. • Link abutment for CEREC All digitally designed copings and/or crowns for use with the Link abutment for CEREC is to be scanned using Sirona CEREC AC or CEREC AF or CEREC AI, designed using Sirona inLab software (Version 3.65) or Sirona CEREC Software (Version 4.2) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. CAD/CAM manufacturing/milling occurs at dental laboratories per the design limitations of the Sirona CEREC. | The ET/SS Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. The abutment is intended for use with a dental implant fixture to provide support for prosthetic restorations such as crowns, bridges, or overdenture. | The Straumann® Variobase® for CEREC® are titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® for CEREC® abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase® for CEREC® abutments are to be inLab software (Version 3.65 or higher) or Sirona CEREC Software (Version 4.2 or higher) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. |
|---|---|---|---|
| Diameter | 4.5mm | 4.6 mm. 5.0 mm, 6.0 mm, 7.0 mm | 4.5 mm – 7.0 mm |
| Post Height | 4.7mm | 4.0 mm , 5.5 mm, 7.0 mm | 4.7mm |
| Implant to | |||
| abutment | |||
| connection type | |||
| / Connection | |||
| mode | HIOSSEN dental | ||
| implants; | |||
| ETIII SA Fixture | |||
| ETIII SA Ultra-Wide | |||
| Fixture | |||
| ETII SA Fixture | |||
| 11° Morse taper internal | |||
| connection | |||
| Mini (Hex, non Hex) | |||
| Regular (Hex, non Hex) | HIOSSEN dental | ||
| implants; | |||
| ETIII SA Fixture | |||
| ETIII SA Ultra-Wide | |||
| Fixture | |||
| ETII SA Fixture | |||
| 11° Morse taper internal | |||
| connection | |||
| Mini (Hex, non Hex) | |||
| Regular (Hex, non Hex) | Straumann dental | ||
| implant platforms: RN | |||
| (Regular Neck), WN | |||
| (Wide Neck), RC | |||
| (Regular CrossFit®), | |||
| and NC (Narrow | |||
| rossFit®) | |||
| Restoration | |||
| angulations | 20° | 0° | 20° |
| Design | Image: HIOSSEN dental implant | Image: HIOSSEN dental implant | Image: Straumann dental implant |
| mesostructure | Compatible with any | ||
| milling blanks cleared | |||
| for use with the CEREC | |||
| MC X and MC XL | |||
| milling systems (i.e., | |||
| containing the pre- | |||
| machined mounting | |||
| hole). Currently | |||
| available: inCoris ZI | |||
| meso (K123664) | |||
| Ivoclar IPS e.max CAD | |||
| (K132209) | |||
| Ivoclar Telio CAD | |||
| (K093708) | - | Compatible with any | |
| milling blanks cleared | |||
| for use with the CEREC | |||
| MC X and MC XL | |||
| milling systems (i.e., | |||
| containing the pre- | |||
| machined mounting | |||
| hole). Currently | |||
| available: inCoris ZI | |||
| meso (K123664) | |||
| Ivoclar IPS e.max CAD | |||
| (K132209) | |||
| Ivoclar Telio CAD | |||
| (K093708) | |||
| Design | |||
| Workflow | Per the Sirona CEREC | ||
| InLab, software version | |||
| 3.65 | - | Per the Sirona CEREC | |
| InLab, software version | |||
| 3.6 or later | |||
| Manufacturing | |||
| Workflow | Per the Sirona Cerec | ||
| MC X and MC XL | |||
| milling systems | - | Per the Sirona Cerec | |
| MC X and MC XL | |||
| milling systems | |||
| SE | Link Abutment for CEREC is almost same with Straumann Variobase for | ||
| CEREC except shape, connection structure, and material but connection | |||
| structure and material are exactly same with Transfer Abutment |
6
Image /page/6/Picture/0 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. There is a small number 6 in the upper right corner of the logo.
OSSTEM Implant Co., Ltd.
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
7
Image /page/7/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. There is a small orange circle with a white "a" in the upper right corner of the logo.
DSSTEM Implant Co., Ltd.
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
The Link Abutment for CEREC is compatible with the following previously cleared materials:
· inCoris ZI, L size blank (Sirona inCoris ZI meso zirconium dioxide, ZrO2) cleared to market per K062509 and K123664
· IPS e.max CAD Abutment Solutions (Ivoclar IPS e.max CAD lithium disilicate glass-ceramic, LS2) cleared to market per K132209
· Telio CAD (Ivoclar Telio CAD polymethylmethacrylate, PMMA) cleared to market per K093708
The Link Abutment for CEREC abutments are compatible with mesostructure fabricated using Sirona Dental CAD/CAM System
-
- Indications for Use Statement
The Link Abutment for CEREC is titanium alloy abutments placed onto HIOSSEN dental implants to provide support for customized prosthetic restorations. Link Abutment for CEREC is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.
- Indications for Use Statement
· Link abutment for CEREC
All digitally designed copings and/or crowns for use with the Link abutment for CEREC is to be scanned using Sirona CEREC AC or CEREC AF or CEREC AI, designed using Sirona inLab software (Version 3.65) or Sirona CEREC Software (Version 4.2) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. CAD/CAM manufacturing/milling occurs at dental laboratories per the design limitations of the Sirona CEREC.
-
- Summary of nonclinical testing
Fatigue testing was considered according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" with the worst case scenario. Sterilization was conducted according to ISO 17665-1:2006. Biocompatibility for the Link Abutment Tibase component is demonstrated by the reference to K120847. All non-clinical testing was conducted for the subject device.
- 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 CO., LTD. concludes that Link Abutment for CEREC is substantially equivalent to the predicate devices as described herein.