Who is the manufacturer of MS SA IMPLANT SYSTEM?

Osstem Implant Co., Ltd. filed the 510(k) submission for MS SA IMPLANT SYSTEM (K122171).

What is the FDA product code for MS SA IMPLANT SYSTEM?

DZE. It is classified under 21 CFR 872.3640 as a Class 2 device in the Dental panel.

What is the regulatory pathway for MS SA IMPLANT SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for MS SA IMPLANT SYSTEM?

MS System (K083067); Straumann Dental Implants (K061176).

Who can help prepare an FDA 510(k) submission like MS SA IMPLANT SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MS SA IMPLANT SYSTEM

K122171 · Osstem Implant Co., Ltd. · DZE · Nov 16, 2012 · Dental

Device Facts

Record ID	K122171
Device Name	MS SA IMPLANT SYSTEM
Applicant	Osstem Implant Co., Ltd.
Product Code	DZE · Dental
Decision Date	Nov 16, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3640
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The MS SA Implant (Denture) is intended to be placed in the bone of the upper or lower jaw arches to provide support of the prosthetic devices to restore the patient's chewing function, including the denture stabilization. The MS SA Implant (Denture) is intended for single use only. It is intended for delayed loading. The MS SA Implant (Narrow Ridge) is intended to use in the treatment of missing mandibular central and lateral incisors to support prosthetic device, such as artificial teeth, in order to restore chewing function in partially edentulous patients. The MS SA Implant (Narrow Ridge) is intended for single use only. It is intended for delayed loading.

Device Story

The MS SA Implant System consists of endosseous dental implants fabricated from titanium alloy (Ti-6Al-4V). The system includes two configurations: a 'Narrow Ridge' implant for mandibular incisor replacement and a 'Denture' implant for jaw arch stabilization. Both feature a threaded body design and a surface treated via sandblasting and acid etching (SA). The device is intended for surgical placement by a dental professional to support prosthetic restorations. The implant provides a stable base for artificial teeth or dentures, restoring chewing function in patients. The system is provided sterile for single use and requires delayed loading protocols.

Clinical Evidence

No clinical studies were submitted. Substantial equivalence is supported by non-clinical bench testing, including fatigue testing conducted in accordance with the FDA guidance document for root-form endosseous dental implants.

Technological Characteristics

Material: Titanium alloy Ti-6Al-4V (ASTM F 136). Surface: Sandblasted and acid-etched (SA). Design: Threaded body, one-body implant. Sterilization: Radiation. Dimensions: Diameters 2.5mm, 2.9mm; Lengths 8.5mm to 13.0mm. Energy source: None (mechanical).

Indications for Use

Indicated for partially edentulous patients requiring restoration of chewing function via support of prosthetic devices (artificial teeth or dentures). Narrow Ridge version indicated for missing mandibular central and lateral incisors. Denture version indicated for upper or lower jaw arch placement for denture stabilization. Intended for single use and delayed loading.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

MS System (K083067)
Straumann Dental Implants (K061176)

Related Devices

K191201 — EM SA Implant System · Hiossen, Inc. · Nov 15, 2019
K083067 — MS SYSTEM · Osstem Implant Co., Ltd. · Feb 2, 2009
K080594 — MS SYSTEM (NARROW RIDGE) · Osstem Implant Co., Ltd. · Sep 3, 2008
K123471 — ETII SA FIXTURE SYSTEM · Hiossen, Inc. · Jul 5, 2013
K121585 — TS IMPLANT SYSTEM · Osstem Implant Co., Ltd. · Jan 7, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ K122171 DSSTEM 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 # 510(k) Summary ## NOV 1 6 2012 This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. Date: July 13, 2012 1. Company and Correspondent making the submission: - Submitter's Name : - Address : - Contact : - Phone: - Correspondent's Name: - Address: - Contact: - Phone: 2. 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 MS SA Implant System Dental Implant Endosseous Dental Implant 21CFR872.3640 Class II DZE ### 3. Predicate Device: MS System, OSSTEM Implant Co., Ltd, K083067 Straumann Dental Implants, Institut Straumann AG, K061176 #### 4. Description: The MS SA Implant System is a dental implant made of titanium alloy (Ti-6Al-4V) metal. The MS SA Implant System 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 surface treatment of MS SA Implant System is SA (Sandblasting and Acid etching). {1}------------------------------------------------ Image /page/1/Figure/1 description: The image shows the logo and contact information for OSSTEM Implant Co., Ltd. The address is #507-8 Geoje3-Dong 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 is www.osstem.com. The MS SA Implant System is substantially equivalent in design, function and intended use to the MS System, OSSTEM Implant Co., Ltd, K083067 The MS SA Implant System is substantially equivalent in surface treatment to the Straumann Dental Implants, Institut Straumann AG, K061176 | | MS SA Implant System (Narrow Ridge) | Predicate devices | | |--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | MS System (Narrow Ridge) | Straumann Dental Implants | | Design | Image: MS SA Implant System (Narrow Ridge) | Image: MS System (Narrow Ridge) | Image: Straumann Dental Implants | | 510(K) No. | New device | K083067 | K061176 | | Intended use | The MS SA Implant (Narrow Ridge) is intended to use in the treatment of missing mandibular central and lateral incisors to support prosthetic device, such as artificial teeth, in order to restore chewing function in partially edentulous patients. The MS SA Implant (Narrow Ridge) is intended for single use only. It is intended for delayed loading. | The MS System (Narrow Ridge) is intended to use in the treatment of missing mandibular central and lateral incisors to support prosthetic device, such as artificial teeth, in order to restore chewing function in partially edentulous patients. MS System (Narrow Ridge) are intended for single use only. | Straumann Regular Neck and Narrow Neck implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used. The Straumann Regular Neck Implants are intended for surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. | | Structure | | | | | - SA(Sandblasting and Acid etching). - Threaded Body Design - One Body Implant | | - R.B.M (Resorbable Blasting Media). - Micro Thread Design. - Threaded Body Design - One Body Implant | -Single Thread -Straight body Type -Non-submerged fixture | | Thread body Diameter (D) | 2.5, 2.9 | 2.5, 3.0 | 3.3~4.8 | | Length (mm) of thread | 8.5, 10.0, 11.5, 13.0 | 8.5, 10.0, 11.5, 13.0, 15.0 | 6.0~16.0 | | Material of Fixture | Titanium alloy Ti-6Al-4V (ASTM F 136) | Titanium alloy Ti-6Al-4V (ASTM F 136) | Pure Titanium Grade 4 (ASTM F67) | | Surface | SA(Sandblasting and Acid etching). | R.B.M (Resorbable Blasting Media). | SLA(Grit blasting, acid etched SLA surface) | | Sterilization | Radiation Sterile | Radiation Sterile | Radiation Sterile | | S E | The MS SA Implant System (Narrow Ridge) has the same material, indication for use and similar design as the MS System (Narrow Ridge) (K083067) except surface treatment. but the surface treatment of The MS SA Implant System (Narrow Ridge) is the similar with surface treatment of Straumann Dental Implants (K061176) | | | | | MS SA Implant System (Denture) | Predicate devices | | | | | MS System (Denture) | Straumann Dental Implants | | | Design | Image: MS SA Implant System (Denture) | Image: MS System (Denture) | | 510(K) No. | New device | K083067 | K061176 | | Intended use | The MS SA Implant (Denture) is intended to be placed in the bone of the upper or lower jaw arches to provide support of the prosthetic devices to restore the patient's chewing function, including the denture stabilization. The MS SA Implant (Denture) is intended for single use only. | The MS System (Denture) is intended to be place in the bone of the upper or lower jaw arches to provide support the prosthetic devices to restore the patient's chewing function, including the denture stabilization. MS System (Denture) is intended for single use only. | Straumann Regular Neck and Narrow Neck implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used. The Straumann Regular Neck Implants are intended for surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients for single-stage or two-stage surgery. The Straumann Narrow Neck implants are intended for surgical placement in the maxilla or mandible to serve as a base for prosthetic reconstructions. Specifically, the Narrow | | | | | Neck implant is indicated for replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible. It is particularly intended for those areas where the interdental space is extremely limited (minimum 5 mm) and where vestibule-oral bone is restricted (minimum 5 mm). The Narrow Neck implant can also be used as a support for a full arch implant-born restoration, but only in conjunction with a standard Straumann 4.1 mm dental implant. | | Structure | - SA(Sandblasting and Acid etching). - Ball-shaped suits for O-Ring attachment. - 2/4mm can be used according to gingival height. - Threaded Body Design | - R.B.M (Resorbable Blasting Media). - Ball-shaped suits for O-Ring attachment. - 2/4mm can be used according to gingival height. - Micro Thread Design. - Threaded Body Design | -Single Thread -Straight body Type -Non-submerged fixture | | Thread body Diameter (D) | 2.5, 2.9 | 2.0, 2.5, 3.0 | 3.3~4.8 | | Length (mm) of thread | 8.5, 10.0, 11.5, 13.0 | 8.5, 11.5 | 6.0~16.0 | | Material of Fixture | Titanium alloy Ti-6Al-4V (ASTM F 136) | Titanium alloy Ti-6Al-4V (ASTM F 136) | Pure Titanium Grade 4 (ASTM F67) | | Surface | SA(Sandblasting and Acid etching). | R.B.M (Resorbable Blasting Media). | SLA(Grit blasting, acid etched SLA surface) | | Sterilization | Radiation Sterile | Radiation Sterile | Radiation Sterile | | SE | The MS SA Implant System (Denture) has the same material, indication for use and similar design as the MS System (Denture) (K083067) except surface treatment. but the surface treatment of The MS SA Implant System (Denture) is the similar with surface treatment of Straumann Dental Implants (K061176) | | | ## - Substantial Equivalence Matrix QS-QI-505-3(Rev.0) {2}------------------------------------------------ K122171 Image /page/2/Picture/1 description: The image shows the logo for Osstem Implant. The logo is in black and white and features the word "OSSTEM" in a stylized font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller font. There is a registered trademark symbol next to 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 . {3}------------------------------------------------ OSSTEM° IMPLANT # 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 QS-QI-505-3(Rev.0) {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is in bold, sans-serif font on the top line. Below that, the word "IMPLANT" is in a smaller, sans-serif font. # 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 ### 5. Indication for use: · The MS SA Implant (Denture) is intended to be placed in the bone of the upper or lower jaw arches to provide support of the prosthetic devices to restore the patient's chewing function, including the denture stabilization. The MS SA Implant (Denture) is intended for single use only. Letter(8.5 X 1 In) {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in a bold, sans-serif font, with the letters slightly overlapping each other. Below the word "OSSTEM", the word "IMPLANT" is written in a smaller, sans-serif font. The logo is simple and modern, and it is likely used to represent a company that specializes in dental implants. 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 The MS SA Implant (Narrow Ridge) is intended to use in the treatment of missing mandibular central and lateral incisors to support prosthetic device; such as artificial teeth, in order to restore chewing function in partially edentulous patients. The MS SA Implant (Narrow Ridge) is intended for single use only. It is intended for delayed loading. - 6. Review: The MS SA Implant System has similar material, indication for use, design and technological characteristics as the predicate device. The MS SA Implant System has been subjected to safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations. - 7. 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 of the MS SA Implant system - 8. Summary of clinical testing No clinical studies are submitted #### 9. 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 MS SA Implant System is substantially equivalent to the predicate devices as described herein. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. 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 emblem featuring a symbol that resembles an abstract human form or a caduceus-like design. #### DEPARTMENT OF HEALTH & HUMAN SERVICES #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002 November 16, 2012 OSSTEM Implant Company, Limited C/O Mr. Patrick Lim Manager HiOSSEN Incorporated 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030 Re: K122171 Trade/Device Name: MS SA Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: September 25, 2012 · Received: September 28, 2012 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 Eederal Register. {7}------------------------------------------------ #### 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 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, DN: r=US o=1) S. Government ou=HHS 0.9.2342.19200300.100.1.1=1300092402 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 {8}------------------------------------------------ ## K122171 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 510(k) Number K 100217 Device Name : MS SA Implant System Indication for use : The MS SA Implant (Denture) is intended to be placed in the bone of the upper or lower jaw arches to provide support of the prosthetic devices to restore the patient's chewing function, including the denture stabilization. The MS SA Implant (Denture) is intended for single use only. It is intended for delayed loading. > The MS SA Implant (Narrow Ridge) is intended to use in the treatment of missing mandibular central and lateral incisors to support prosthetic device, such as artificial teeth, in order to restore chewing function in partially edentulous patients. The MS SA Implant (Narrow Ridge) is intended for single use only. It is intended for delayed loading. X Prescription Use (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. Runn Marv S. Runner DA. Ou=People, cn=Mary 5, Run (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices - 】 - 510(k) Number: K12217 1 OS-QI-505-2(Rev.0)