BLT Dental Implant System
Device Facts
| Record ID | K212364 |
|---|---|
| Device Name | BLT Dental Implant System |
| Applicant | Bio Concept Co., Ltd. |
| Product Code | DZE · Dental |
| Decision Date | Aug 10, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
BLT Dental Implant Systems are intended to be placed in the upper and lower jaw to support prosthetic devices and to restore a patient's chewing function. BLT Dental Implant systems are also indicated for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments). In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.
Device Story
BLT Dental Implant System consists of endosseous dental implants, healing caps, and abutments; used for oral rehabilitation of edentulous/partially dentate patients. Implants are placed in upper/lower jaw via one or two-stage surgery; provide support for prosthetic restorations (crowns, bridges, dentures). Device features internal Crossfit connection, tapered body, and self-tapping 3-sided cutting edge. Operates by integrating with bone to restore chewing function. Used by dental professionals in clinical settings. Output is a stable foundation for prosthetic devices. Benefits include restoration of aesthetics and masticatory function. Components include various diameters/lengths to accommodate patient anatomy.
Clinical Evidence
No clinical data. Bench testing only. Mechanical fatigue testing performed per ISO 14801. Biocompatibility evaluated per ISO 10993-1, -5, -10, -11. Sterilization validated per ISO 11137-2 and ISO 17665-1. Packaging integrity verified per ASTM standards (F1980, D3078, F88, F1886, F1929, F2096).
Technological Characteristics
Materials: Pure Titanium (implants), Titanium Alloy (abutments/caps). Sensing/Actuation: Mechanical endosseous fixation. Dimensions: Implants Ø3.38-4.8mm, lengths 8.1-18.2mm. Connectivity: None. Sterilization: Gamma irradiation (SAL 10^-6). Design: Internal Crossfit connection, tapered body, self-tapping 3-sided cutting edge.
Indications for Use
Indicated for edentulous and partially dentate patients requiring oral endosteal implantation in the upper or lower jaw to support prosthetic devices (crowns, bridges, dentures) and restore chewing function. Suitable for immediate or early implantation post-extraction/tooth loss. Immediate function permitted for single or multiple teeth if primary stability and occlusal loading criteria are met. Fully edentulous patients require 4+ implants for immediate 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
- Dental Implant System (K150388)
Reference Devices
- Straumann Bone Level Tapered Implants (K153758)
- STRAUMANN P.004 CEMENTABLE ABUTMENTS, TEMPORARY COPINGS AND PROTECTIVE CAPS (K072071)
- CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS (K080286)
- STRAUMANN RC TEMPORARY ABUTMENTS (K093027)
- Straumann Screw-Retained Abutments (K192401)
- Straumann Screw Retained Abutments (K171757)
- Osstem Abutment System (K182091)
- STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS (K130808)
- P.004 HEALING ABUTMENTS AND CLOSURE SCREWS (K071585)
- STRAUMANN MAGELLAN(TM) ABUTMENT,PROTECTIVE CAP,TITANIUM COPINGS,GOLD CHOPINGS,BASAL SCREW (K133421)
- OT EQUATOR (K171409)
- OSSTEM Implant System - Abutment (K161689)
- STRAUMANN DENTAL ABUTMENTS (K092814)
Related Devices
- K212517 — Magicore System · Innobiosurg Co., Ltd. · Oct 15, 2021
- K162482 — A.B. DENTAL DEVICES Dental Implants System · A.B. Dental Device , Ltd. · Sep 15, 2017
- K112440 — AB DENTAL DEVICES IMPLANTS AND ACCESSORIES · A.B. Dental Devices , Ltd. · Apr 18, 2012
- K151928 — PUR Dental Implant System · Sterngold Dental, LLC · Nov 6, 2015
- K071148 — ATLAS IMPLANT SYSTEM · Cowellmedi Co., Ltd. · Feb 6, 2008
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Bio Concept Co., Ltd % Diana Hong General Managr Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CHINA
Re: K212364
Trade/Device Name: BTL Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: June 13, 2022 Received: July 11, 2022
Dear Diana Hong:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
## Indications for Use
510(k) Number (if known) K212364
Device Name
BLT Dental Implant System
#### Indications for Use (Describe)
BLT Dental Implant Systems are intended to be placed in the upper and lower jaw to support prosthetic devices and to restore a patient's chewing function. BLT Dental Implant systems are also indicated for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments). In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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# Tab # 6 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: _K212364
- 1. Date of Preparation: 08/09/2022
- 2. Sponsor Identification
### BIO CONCEPT CO., LTD
Unit C, No.26, Huashan Middle Road, Xinbei Zone, Changzhou, Jiangsu 213022, China Establishment Registration Number: 3012465917
Contact Person: Tianshui Li Position: General Manager Tel: +86-519-85172266 Fax: +86-519-85172299 Email: daixiaodong(@bioconcept.cn
- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)
Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
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#### 4. Identification of Proposed Device
Trade Name: BLT Dental Implant System Common Name: Endosseous dental implant
Regulatory Information Classification Name: Endosseous implant Classification: II Regulation Number: 21 CFR 872.3640 Primary Product Code: DZE Secondary Product Code: NHA Review Panel: Dental
Indications for Use
BLT Dental Implant Systems are intended to be placed in the upper and lower jaw to support prosthetic devices and to restore a patient's chewing function. BLT Dental Implant systems are also indicated for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments). In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.
### Device Description
The proposed devices, BLT Dental Implant Systems, are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. The proposed devices can also be used for immediate or early implantation following extraction or loss of natural teeth.
The proposed device contains dental implant, healing cap and abutment. The dental implant system is available in two types, NC type and RC type.
| Ref | Name | Type | Diameter | Length |
|--------|---------|------|-----------|----------|
| 115010 | Implant | NC | Φ3.38±0.1 | 8.1±0.2 |
| 115020 | Implant | NC | Φ3.38±0.1 | 10.1±0.2 |
| 115030 | Implant | NC | Φ3.38±0.1 | 12.1±0.2 |
Table 1. Body Size of Dental Implants (Unit: mm)
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| 115040 | Implant | NC | $Φ3.38±0.1$ | 14.1±0.2 |
|--------|---------|----|-------------|----------|
| 115050 | Implant | NC | $Φ3.38±0.1$ | 16.1±0.2 |
| 115060 | Implant | NC | $Φ3.38±0.1$ | 18.1±0.2 |
| 116010 | Implant | RC | $Φ4.15±0.1$ | 8.2±0.2 |
| 116020 | Implant | RC | $Φ4.15±0.1$ | 10.2±0.2 |
| 116030 | Implant | RC | $Φ4.15±0.1$ | 12.2±0.2 |
| 116040 | Implant | RC | $Φ4.15±0.1$ | 14.2±0.2 |
| 116050 | Implant | RC | $Φ4.15±0.1$ | 16.2±0.2 |
| 116060 | Implant | RC | $Φ4.15±0.1$ | 18.2±0.2 |
| 117010 | Implant | RC | $Φ4.8±0.1$ | 8.2±0.2 |
| 117020 | Implant | RC | $Φ4.8±0.1$ | 10.2±0.2 |
| 117030 | Implant | RC | $Φ4.8±0.1$ | 12.2±0.2 |
| 117040 | Implant | RC | $Φ4.8±0.1$ | 14.2±0.2 |
| 117050 | Implant | RC | $Φ4.8±0.1$ | 16.2±0.2 |
| 117060 | Implant | RC | $Φ4.8±0.1$ | 18.2±0.2 |
The healing cap can be divided into closure screw, healing abutment and protective Cap. Abutment can be divided into anatomic abutment, meso abutment, cementable abutment, equator abutment, Screw-retained abutment and coping. And it is available in NC, crown, bridge, A Type and B Type.
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- ર. Identification of Predicate Device
510(k) Number: K150388 Product Name: Dental Implant System Manufacturer: BIO CONCEPT CO., LTD.
- 6. Identification of Reference Devices
Reference Device 1 510(k) Number: K153758 Device Name: Straumann Bone Level Tapered Implants Manufacturer: INSTITUT STRAUMANN AG
Reference Device 2 510(k) Number: K072071 Device Name: STRAUMANN P.004 CEMENTABLE ABUTMENTS, TEMPORARY COPINGS AND PROTECTIVE CAPS Manufacturer: Institut Straumann AG
Reference Device 3 510(k) Number: K080286 Device Name: CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS Manufacturer: STRAUMANN USA
Reference Device 4 510(k) Number: K093027 Device Name: STRAUMANN RC TEMPORARY ABUTMENTS Manufacturer: STRAUMANN USA
Reference Device 5 510(k) Number: K192401 Device Name: Straumann Screw-Retained Abutments Manufacturer: Straumann USA, LLC
Reference Device 6 510(k) Number: K171757 Device Name: Straumann Screw Retained Abutments Manufacturer: Straumann USA, LLC (On Behalf Of Institut Straumann AG)
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Reference Device 7 510(k) Number: K182091 Device Name: Osstem Abutment System Manufacturer: Osstem Implant Co., Ltd.
Reference Device 8 510(k) Number: K130808 Device Name: STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS Manufacturer: STRAUMANN USA
Reference Device 9 510(k) Number: K071585 Device Name: P.004 HEALING ABUTMENTS AND CLOSURE SCREWS Manufacturer: STRAUMANN USA
Reference Device 10 510(k) Number: K133421 Device Name: STRAUMANN MAGELLAN(TM) ABUTMENT,PROTECTIVE CAP,TITANIUM COPINGS,GOLD CHOPINGS,BASAL SCREW Manufacturer: STRAUMANN USA, LLC
Reference Device 11 510(k) Number: K171409 Device Name: OT EQUATOR Manufacturer: Rhein'83 SRL
Reference Device 12 510(k) Number: K161689 Device Name: OSSTEM Implant System - Abutment Manufacturer: OSSTEM IMPLANT Co., Ltd.
Reference Device 13 510(k) Number: K092814 Device Name: STRAUMANN DENTAL ABUTMENTS Manufacturer: STRAUMANN MANUFACTURING, INC.
- 7. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device and reference devices.
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Mechanical test was performed on both the proposed device and prediate device according to FDA guidance and ISO 14801. The test result does not show any significant difference.
The patient contact materials of the proposed device, BLT Dental Implant System, are identical to the material of BV Dental Implant System as it was cleared in K192274 in 06/18/2020. in formulation, processing and sterilization, and no other chemicals have been added. (e.g., plasticizers, filters, color additives, cleaning agents, mold release agents, etc.). Therefore, new biocompatibility test were not conducted on the proposed device.
The subject dental implant were sterilized by irradiation to achieve a SAL of 106 and the sterilization method was validated in accordance ISO 11137-2. Vacuum leak test and sterility test were provided to verify the package integrity.The package process for the proposed device is same as Dental Implant System as it was cleared in K150388 in 11/12/2015. Therefore, new package integrity test was not conducted on the proposed device. Besides, bacteria endotoxin limit were evaluated for the each lot device.
The modified surface for the proposed device is same as Dental Implant System as it was cleared in K150388 in 11/12/2015 which is also manufactured by the sponsor. Therefore, the chemical analysis of the surface will leverage on the test report performed on the device K150388 instead of performing a new test.
The test results demonstrated that the proposed device complies with the following standards:
- > ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- > ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Test for in vitro Cytotoxicity
- > ISO 10993-10:2010 Biological evaluation of medical Devices-Part 10: Test for irritation and skin sensitization
- > ISO 10993-11:2017, Biological evaluation of medical Devices-Part 11: Test for systemic toxicity
- > ISO 14801:2016 Dentistry-Implants-Dynamic fatigue test for endosseous dental implants
- > USP <85> Bacterial Endotoxin Test
- > ASTM F136-13, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications
- > ASTM F67-13 (Reapproved 2017), Standard Specification for Unalloyed Titanium for Surgical Implant Applications
- > ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
- > ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
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- A AAMI TIR 30:2011 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
- > USP <85> Bacterial Endotoxins Test
- > ASTM F1980-07(2011) Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- A ASTM D3078-02(2013) Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
- > ISO 11737-2: 2009 Sterilization of edical Devices-Microbiological Methods-Part 2: Tests of Sterility Performed in the Definition, Validation and Maintenance of a Sterilization Process.
- > ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- A ISO 11607-1:2019 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
- > ISO 11607-2:2019 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
- > ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
- A ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
- A ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dve Penetration
- > ASTM F2096-11 (Reapproved 2019) Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
- 8. Clinical Test Conclusion
No clinical study is included in this submission.
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### 9. Summary of Technological characteristics
| ITEM | Proposed Device | Predicate Device K150388 | Reference Device 1 K153758 | Remark |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product Code | DZE | DZE | DZE | Same |
| Regulation No. | 872.3640 | 872.3640 | 872.3640 | Same |
| Classification | II | II | II | Same |
| Indication for use | BLT Dental Implant systems are intended to be placed in the upper and lower jaw to support prosthetic devices and to restore a patient's chewing function. BLT Dental Implant systems are also indicated for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the | Dental implant systems are intended to be placed in the upper and lower jaw to support prosthetic devices and to restore a patient's chewing function. Dental implant systems are also indicated for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components | Straumann® Bone Level Tapered Implants are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. Straumann Bone Level Tapered Implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial | Different |
| | corresponding<br>components<br>(abutments). In cases of fully<br>edentulous patients, 4 or more<br>implants must be used in<br>immediately loaded cases. | (abutments). In cases of fully<br>edentulous patients, 4 or more<br>implants must be used in<br>immediately loaded cases. | or full dentures, which are<br>connected to the implants by the<br>corresponding elements<br>(abutments). | |
| Surgery type | One or two stage Surgery | One or two stage Surgery | One or two stage Surgery | Same |
| Structure | - Internal Crossfit connected<br>- Submerged Implant<br>- Tapered body shape<br>- 3 sided cutting edge with<br>self-tapping | - Internal Crossfit connected<br>- Submerged Implant<br>- Straight body shape | - Internal Crossfit connected<br>- Submerged Implant<br>- Straight body shape | Same |
| Coronal Thread<br>Form | Constant major and minor thread<br>diameters (i.e., parallel wall)<br>0.8mm thread pitch | Constant major and minor thread<br>diameters (i.e., parallel wall)<br>0.8mm thread pitch | Constant major and minor thread<br>diameters (i.e., parallel wall)<br>0.8mm thread pitch | Same |
| Apical<br>Thread<br>Form | Angled major and minor thread<br>diameters (i.e., tapered wall), with<br>the major and minor diameters<br>have differing angles such that the<br>depth increases toward the apical<br>end of the implant and the<br>addition of cutting flutes.<br>0.8mm thread pitch | Constant major and minor thread<br>diameters<br>(i.e., parallel wall)<br>0.8mm thread pitch | Constant major and minor thread<br>diameters<br>(i.e., parallel wall)<br>0.8mm thread pitch | Different |
| Body<br>Diameter (D) | Ø3.3mm, Ø4.1mm, Ø4.8mm | Ø3.3mm, Ø4.1mm, Ø4.8mm | Ø3.3mm, Ø4.1mm, Ø4.8mm | Same |
| Implant Length | 8, 10, 12, 14, 16, 18mm | 8, 10, 12, 14mm | 18 mm | Different |
| Material<br>of | Pure Titanium | Pure Titanium | Titanium zirconium alloy | Different |
| Fixture | | | | |
| Surface | Sand blasted and acid etched | Sand blasted and acid etched | Sand blasted and acid etched | Same |
| Sterilization | Radiation Sterile | Radiation Sterile | Radiation Sterile | Same |
| Shelf life | 5 years | 5 years | / | Same |
Table 2. Characteristic Comparison for Implant
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### Different – Indication for Use
The indications for use for the proposed device is the predicated device. In addition, although the description of indications for use for the proposed device is different from that of the reference device K153758, in fact the same. Therefore, this difference will not affect substantially equivalence on safety and effectiveness.
### Different - Apical Thread Form
The difference in structure does, in addition, mechanical test has been conducted on the proposed device and predicate device and the test result does not show any significant difference will not affect substantially equivalence on safety and effectiveness.
### Different - Implant Length
The implant length range of the proposed device can be cover and reference device K153758. Therefore, this difference will not affect substantially equivalence on safety and effectiveness.
### Different - Material of Fixture
The material of fixture of the same as that of the predicated device. Therefore, this difference will not affect substantially equivalence on safety and effectiveness.
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| Anatomic Abutment | | | | |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| ITEM | Proposed Device | Reference Device K072071 | Reference Device K080286 | Remark |
| Indications for Use | Abutments are intended to be<br>placed into dental implants to<br>provide support for prosthetic<br>reconstructions such as crowns,<br>bridges and overdentures. | Abutments are intended to be<br>placed into dental implants to<br>provide support for prosthetic<br>reconstructions such as crowns,<br>bridges and overdentures. | Abutments are intended to be<br>placed into dental implants to<br>provide support for prosthetic<br>reconstructions such as crowns,<br>bridges and overdentures. | Same |
| Principle of Operation | Using making for general<br>cement-type prosthesis. | Using making for general<br>cement-type prosthesis. | Using making for general<br>cement-type prosthesis. | Same |
| Interface Type | Engaging | Engaging | Engaging | Same |
| Angle | 0°, 15° | 0°, 15° | 0°, 15° | Same |
| Gingiva Height (mm) | 2, 3.5 | 2, 3.5 | 2, 3.5 | Same |
| Material | Titanium alloy | Titanium alloy | Titanium alloy | Same |
| Cementable Abutment | | | | |
| ITEM | Proposed Device | Reference Device K072071 | Reference Device K080286 | Remark |
| Indications for Use | Abutments are intended to be<br>placed into dental implants to<br>provide support for prosthetic<br>reconstructions such as crowns,<br>bridges and overdentures. | Abutments are intended to be<br>placed into dental implants to<br>provide support for prosthetic<br>reconstructions such as crowns,<br>bridges and overdentures. | Abutments are intended to be<br>placed into dental implants to<br>provide support for prosthetic<br>reconstructions such as crowns,<br>bridges and overdentures. | Same |
| Principle of Operation | Using making for general<br>cement-type prosthesis. | Using making for general<br>cement-type prosthesis. | Using making for general<br>cement-type prosthesis. | Same |
| Interface Type | Engaging | Engaging | Engaging | Same |
| Gingiva Height (mm) | 1.3, 1.35, 2.3, 2.35, 3.3, 3.35 | 1, 2, 3, 4, 5, 6 | 1, 2, 3, 4, 5, 6 | Different |
| Material | Titanium alloy | Titanium alloy | Titanium alloy | Same |
| Temporary Abutment | | | | |
| ITEM | Proposed Device | Reference Device K093027 | Reference Device K092814 | Remark |
| Indications for Use | Temporary Abutments are<br>intended for use in Bone Level<br>Dental Implant for temporary<br>restorations of single crowns and<br>bridges for up to six months. | The Straumann RC Temporary<br>Abutments are indicated for use<br>in Straumann RC bone level<br>implants for temporary<br>restorations of single crowns and<br>bridges for up to six months. | The Straumann NC Temporary<br>Abutments are indicated for use<br>in Straumann NC Bone Level<br>Implants for temporary<br>restorations of single crowns and<br>bridges for up to six months. | Same |
| Principle of Operation | Cement retained restoration; using<br>making temporary prosthesis to<br>maintain aesthetic appearance until<br>final prosthesis is made. | Cement retained restoration;<br>using making temporary<br>prosthesis to maintain aesthetic<br>appearance until final prosthesis<br>is made. | Cement retained restoration;<br>using making temporary<br>prosthesis to maintain aesthetic<br>appearance until final prosthesis<br>is made. | Same |
| Interface Type | Engaging/Non-engaging | Engaging/Non-engaging | Engaging/Non-engaging | Same |
| Angle | Straight | Straight | Straight | Same |
| Diameter (mm) | 3.5, 4.5 | 4.5 | 3.5 | Same |
| Height (mm) | 11 | 11 | 11 | Same |
| Material | Titanium alloy | Pure Titanium | Titanium alloy | Different |
| Screw-retained Abutment | | | | |
| ITEM | Proposed Device | Reference Device K171757 | | Remark |
| Indications for Use | Screw Retained Abutments are<br>indicated to be placed into the<br>implants of the Dental Implant<br>System to provide support for<br>prosthetic reconstructions such as<br>crowns, bridges and bars. The final<br>processed devices have the<br>purpose of restoring chewing | Screw Retained Abutments are indicated to be placed into the<br>implants of the Dental Implant System to provide support for<br>prosthetic reconstructions such as crowns, bridges and bars. The<br>final processed devices have the purpose of restoring chewing<br>function. Screw Retained Abutments are indicated for screw-retained<br>restorations. | | Same |
| | function. Screw Retained<br>Abutments are indicated for<br>screw-retained restorations. | | | |
| Principle of Operation | Using making for general<br>screw-retained prosthesis. | Using making for general screw-retained prosthesis.…
