(139 days)
Dentium Prosthetics are intended for use as an aid in prosthetic rehabilitation.
The purpose of this submission is to change the sterilization method of Healing Abutments and Cover Screws. These devices which have been provided non-sterilized by gamma radiation.
Healing Abutments are used provisionally as an accessory to endosseous dental implant during healing period to prepare gingival tissue for acceptance of a final abutment. Healing Abutments are designed to aid in soft tissue contouring during the healing period after implant placement, creating an emergence profile for the final abutment. Cover Screws are used provisionally as an accessory to protect the inner features of the implant.
The Healing Abutments and Cover Screws are prefabricated and made of Ti-6Al-4V ELI (ASTM F136). These devices are sterilized using gamma radiation method and intended for single use only.
The provided document is a 510(k) premarket notification for "Healing Abutments and Cover Screws." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific performance acceptance criteria through the kind of rigorous, large-scale studies typically associated with AI/ML-based medical devices or novel technologies.
Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this specific submission. This document describes a change in the sterilization method for existing devices, not a new device with performance metrics that require extensive clinical validation studies beyond sterilization and biocompatibility.
Here's an analysis based on the information available in the document:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission concerning a change in sterilization method for mechanical components like healing abutments and cover screws, the "acceptance criteria" revolve around demonstrating that the new sterilization method achieves the required sterility assurance level and does not adversely affect the device's material properties or function, maintaining its substantial equivalence to the predicate.
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance/Evidence |
|---|---|---|
| Sterilization Efficacy | Achieve a Sterility Assurance Level (SAL) of 10^-6, in accordance with recognized standards. | "Gamma radiation sterilization validation according to ISO 111137-1 and ISO 11137-2, demonstrating a sterility assurance level (SAL) of 10^-6." (Page 4) |
| Biocompatibility | The device material (Ti-6Al-4V ELI (ASTM F136)) must be biocompatible and the sterilization process must not negatively impact biocompatibility. | "Biocompatibility of Ti-6A1-4V ELI (ASTM F136) demonstrated by the referenced Dentium submission, K041368, using the identical materials and manufacturing processes including sterilization as the subject device." (Page 4) |
| Material Integrity/Shelf-life | The sterilization process should not degrade the material or product function over its intended shelf-life. | "Accelerated and real time aging studies according to ASTM F1980 demonstrating a shelf life." (Page 4) |
| Functional Equivalence | The design, materials, and intended use of the device must remain substantially equivalent to previously cleared versions (predicates), despite the change in sterilization. This is demonstrated by comparing technological characteristics like material, form, connection type, dimensions, and indication for use. The only noted difference between the subject device and the primary predicate device for both healing abutments and cover screws is the sterilization method (Pages 7, 9). | The document states that the subject devices (Healing Abutments and Cover Screws) have the "same characteristics for the followings compared to the primary predicate device: Indication for use, Material, Connection type, Dimension" (for Healing Abutments, Page 7) and "Indication for use, Material, Dimension" (for Cover Screws, Page 9). Dimensions are extensively compared and shown to match various predicates (Pages 6-7, 9). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated as a separate "test set" in the context of clinical performance data typical for AI/ML devices. The "tests" here are primarily engineering and laboratory validations:
- Sterilization Validation: ISO 11137 standards define the number of units and replicates required for sterility testing (e.g., bioburden determination, dose mapping, sterility testing), which are often small, specific lots. This is standard laboratory validation, not a patient-based test set.
- Aging Studies: ASTM F1980 dictates sample sizes for accelerated aging, again, laboratory testing of physical samples.
- Biocompatibility: Relies on a prior submission (K041368) which presumably included its own biocompatibility testing. No new "sample size" for a clinical test set is mentioned for biocompatibility here.
- Data Provenance: The studies are laboratory-based ("Non-clinical testing data"). The manufacturer is located in the Republic of Korea (Dentium Co., Ltd.). The data would be derived from their internal validation processes. It is neither retrospective nor prospective in the sense of patient studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This submission does not involve image interpretation or clinical diagnosis where expert ground truth would be established. The "ground truth" for sterilization is a defined SAL, verified by microbiological and physical testing per ISO standards. The "ground truth" for material properties is based on ASTM standards and prior biocompatibility data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As there is no clinical "test set" based on human interpretation or an AI algorithm's output requiring adjudication, this concept does not apply.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is a traditional medical device (dental implants and accessories), not an AI-assisted diagnostic or therapeutic device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this submission is based on:
- Standardized Sterility Assurance: Achieving a defined SAL of 10^-6, verified through validated sterilization processes and testing compliant with ISO 11137-1 and ISO 11137-2.
- Material Standards: Biocompatibility established against Ti-6Al-4V ELI (ASTM F136) as per regulations and previous submissions.
- Engineering Performance: Shelf-life demonstrated through accelerated and real-time aging studies per ASTM F1980.
- Substantial Equivalence: Demonstrated by comparing engineering specifications and intended use against legally marketed predicate devices.
8. The sample size for the training set
- Not Applicable. This involved physical device manufacturing and validation, not machine learning model training.
9. How the ground truth for the training set was established
- Not Applicable. (See point 8)
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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 23, 2020
Dentium Co., Ltd. Byung-Sun Kim RA Team Manager 150, Eondong-ro Giheung-gu Yongin-si 446-914 REPUBLIC OF KOREA
Re: K192436
Trade/Device Name: Healing Abutments and Cover Screws Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: January 21, 2020 Received: January 23, 2020
Dear Byung-Sun 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. 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 (OS) 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.
for
Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental 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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Indications for Use
510(k) Number (if known) K192436
Device Name Healing Abutments and Cover Screws
| Indications for Use (Describe) | Dentium Prosthetics are intended for use as an aid in prosthetic rehabilitation. |
|---|---|
| -------------------------------- | ---------------------------------------------------------------------------------- |
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C |
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
1. Company
| Submitter | |
|---|---|
| Name | Dentium Co., Ltd. |
| Address | 150, Eondong-ro, Giheung-gu, Yongin-si, Gyeonggi-do, Korea (16985) |
| Phone/Fax | Tel. +82-70-7098-8806, Fax. +82-31-8019-9131 |
| Contact person | Byung-sun Kim / RAbskim@dentium.com |
| Summary Date | 01/17/2020 |
2. Device Name
| Proprietary name | : Healing Abutments and Cover Screws |
|---|---|
| Regulation number | : 21 CFR 872.3630 |
| Regulation Description | : Endosseous dental implant abutment |
| Product code | : NHA |
| Device class | : Class II |
| Classification Panel | : Dental Products Panel |
| Reviewing Branch | : Dental Devices Branch |
3. Predicate Device
Primary Predicate
K052957 Implantium Abutments
Reference Predicate
| K041368 | Implantium |
|---|---|
| K112045 | SimpleLine II Abutment System |
| K141457 | Dentium Implantium® and SuperLine® Abutment |
| K153268 | NR Line Implant System |
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Dentium Implantium & SuperLine Prosthetics K172640
4. Indication for use
Dentium Prosthetics are intended for use as an aid in prosthetic rehabilitation.
5. Description
The purpose of this submission is to change the sterilization method of Healing Abutments and Cover Screws. These devices which have been provided non-sterilized by gamma radiation.
Healing Abutments are used provisionally as an accessory to endosseous dental implant during healing period to prepare gingival tissue for acceptance of a final abutment. Healing Abutments are designed to aid in soft tissue contouring during the healing period after implant placement, creating an emergence profile for the final abutment. Cover Screws are used provisionally as an accessory to protect the inner features of the implant.
The Healing Abutments and Cover Screws are prefabricated and made of Ti-6Al-4V ELI (ASTM F136). These devices are sterilized using gamma radiation method and intended for single use only.
6. Performance Data
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included:
· Gamma radiation sterilization validation according to ISO 111137-1 and ISO 11137-2, demonstrating a sterility assurance level (SAL) of 10-6.
- · Accelerated and real time aging studies according to ASTM F1980 demonstrating a shelf life.
· Biocompatibility of Ti-6A1-4V ELI (ASTM F136) demonstrated by the referenced Dentium submission, K041368, using the identical materials and manufacturing processes including sterilization as the subject device.
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7. Technological Characteristics
The following comparison table of the technological characteristics of the subject device and the predicate devices outlines and provides the similarities and the substantial equivalency of the subject device and the predicate.
7.1 Healing Abutment
| Subject device | PrimaryPredicate | Reference predicate | ||||
|---|---|---|---|---|---|---|
| Device name | HealingAbutments andCover Screws | ImplantiumAbutments(HealingAbutment) | Implantium(HealingAbutment) | SimpleLine IIAbutmentSystem(HealingAbutment) | NR LineImplant System(HealingAbutment) | DentiumImplantium &SuperLineProsthetics(HealingAbutment) |
| Manufacturer | Dentium Co.,Ltd. | Dentium Co.,Ltd. | Dentium Co.,Ltd. | Dentium Co.,Ltd. | Dentium Co.,Ltd. | Dentium Co.,Ltd. |
| 510(k) Number | K192436 | K052957 | K041368 | K112045 | K153268 | K172640 |
| Indication foruse | DentiumProsthetics areintended for useas an aid inprostheticrehabilitation. | ImplantiumProsthetics isintended for useas an aid inprostheticrehabilitation. | The DentiumCo LtdImplantium isintended to besurgicallyplaced in thebone of theupper or lowerjaw arches toprovide supportfor prostheticdevices, such asartificialteeth, and torestore thepatient'schewingfunction. | The SimpleLineII Abutmentsystem isintended for useas an aid inprostheticrehabilitation. | The NR LineImplantsSystem isindicated foruse in surgicaland restorativeapplications forplacement inthe bone of theupper or lowerjaw to providesupport forprostheticdevices, such asartificial teeth,in order torestore thepatient'schewingfunction. NRLine ImplantSystem isindicated alsofor immediateloading when | DentiumImplantium® &SuperLine®Prosthetics areintended for useas an aid inprostheticrehabilitation. |
Comparison of Characteristics
510(k) Summary
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| good primarystability isachieved andwithappropriateocclusalloading. | |||||||
|---|---|---|---|---|---|---|---|
| Materials | Ti-6Al-4V ELI(ASTM F136) | Ti-6Al-4V ELI(ASTM F136) | Ti-6Al-4V ELI(ASTM F136) | Ti-6Al-4V ELI(ASTM F136) | Ti-6Al-4V ELI(ASTM F136) | Ti-6Al-4V ELI(ASTM F136) | |
| Form | Preformed | Preformed | Preformed | Preformed | Preformed | Preformed | |
| Connectiontype | Internal | Internal | Internal | Internal | Internal | Internal | |
| Sterilization | Sterile(GammaRadiation) | Non-sterile | Sterile(GammaRadiation) | Non-sterile | Non-sterile | Non-sterile | |
| Use | Prescription | Prescription | Prescription | Prescription | Prescription | Prescription | |
| Single Use Only | Yes | Yes | Yes | Yes | Yes | Yes |
Dimension comparison
| Image | Dimension (mm) | ||
|---|---|---|---|
| Subject device(K192436) | Image: implant | Diameter | 4.04 / 4.10 / 4.14 / 4.20 / 4.50 / 4.54 / 4.64 / 4.70 / 5.50 / 5.54 / 5.64 / 5.75 /6.50 / 6.54 / 6.64 / 6.75 / 7.64 / 8.64 / 9.64 |
| Length | 8.70 / 10.91 / 10.93 / 11.04 / 11.15 / 12.41 / 12.44 / 12.55 / 12.65 / 12.66 /14.42 / 14.44 / 14.55 / 14.66 | ||
| Image: implant | Diameter | 4.16 / 4.53 / 5.02 / 5.23 / 6.22 / 6.43 | |
| Length | 10.52 / 10.55 / 12.26 / 12.28 / 14.25 / 14.27 | ||
| Image: implant | Diameter | 4.80 / 6.50 | |
| Length | 6.15 / 6.30 / 7.15 / 7.30 / 8.15 / 8.30 / 9.15 / 9.30 | ||
| Image: implant | Diameter | 3.70 / 4.30 / 5.50 / 6.50 / 7.50 / 8.50 / 9.50 | |
| Length | 8.10 / 8.60 / 10.10 / 12.10 | ||
| Image: implant | Diameter | 4.04 / 4.12 / 4.14 / 4.20 / 4.50 / 4.54 / 4.64 / 4.70 / 5.50 / 5.45 / 5.64 / 5.75 /6.50 / 6.54 / 6.64 / 6.74 / 7.54 / 7.64 / 8.54 / 8.64 / 9.54 / 9.64 | |
| Length | 8.88 / 8.89 / 8.90 / 10.81 / 10.83 / 10.96 / 11.05 / 11.06 / 11.09 / 12.31 / 12.34 /12.45 / 12.55 / 12.56 / 12.57 / 14.32 / 14.34 / 14.51 / 14.56 | ||
| Predicate device | |||
| K052957 | Image: implant | Diameter | 4.04 / 4.10 / 4.14 / 4.20 / 4.50 / 4.54 / 4.64 / 4.70 / 5.50 / 5.54 / 5.64 / 5.75 /6.50 / 6.54 / 6.64 / 6.75 / 7.64 / 8.64 / 9.64 |
| Length | 8.70 / 10.91 / 10.93 / 11.04 / 11.15 / 12.41 / 12.44 / 12.55 / 12.65 / 12.66 /14.42 / 14.44 / 14.55 / 14.66 |
510(k) Summary
Page 4 of 8
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K192436
| K041368 | Image: dental implant | Diameter | 4.16 / 4.53 / 5.02 / 5.23 / 6.22 / 6.43 |
|---|---|---|---|
| Length | 10.52 / 10.55 / 12.26 / 12.28 / 14.25 / 14.27 | ||
| K112045 | Image: dental implant | Diameter | 4.80 / 6.50 |
| Length | 6.15 / 6.30 / 7.15 / 7.30 / 8.15 / 8.30 / 9.15 / 9.30 | ||
| K153268 | Image: dental implant | Diameter | 3.70 / 4.30 / 5.50 / 6.50 / 7.50 / 8.50 / 9.50 |
| Length | 8.10 / 8.60 / 10.10 / 12.10 | ||
| K172640 | Image: dental implant | Diameter | 4.04 / 4.12 / 4.14 / 4.20 / 4.50 / 4.54 / 4.64 / 4.70 / 5.50 / 5.45 / 5.64 / 5.75 /6.50 / 6.54 / 6.64 / 6.74 / 7.54 / 7.64 / 8.54 / 8.64 / 9.54 / 9.64 |
| Length | 8.88 / 8.89 / 8.90 / 10.81 / 10.83 / 10.96 / 11.05 / 11.06 / 11.09 / 12.31 / 12.3412.45 / 12.55 / 12.56 / 12.57 / 14.32 / 14.34 / 14.51 / 14.56 |
1) Similarities
The subject Healing Abutments have the same characteristics for the followings compared to the primary predicate device.
- Indication for use, Material, Connection type, Dimension
The subject Healing Abutments have the same dimensions cleared under K052957. K041368. K112045, K153268 and K172640.
2) Differences
The subject Healing Abutments have the different characteristic for the following compared to the primary predicate device.
- Sterilization Method
3) Discussion
The purpose of this submission is to change the sterilization method of Healing Abutments previously cleared under K052957, K041368, K112045, K153268 and K172640. These Healing Abutments which have been provided non-sterile will be sterilized by gamma radiation. In terms of sterilization method there is difference between the subject device and primary predicate device. However, the reference device K041368 is sterilized via gamma radiation as the subject device. And the sterilization method of subject device was validated according to ISO 111137-1 and ISO 11137-2, demonstrating a sterility assurance level (SAL) of 10-6
In conclusion, the subject device is substantially equivalent to the predicate device because it is verified that the difference does not affect substantial equivalence.
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7.2 Cover Screw
Comparison of Characteristics
| PrimarySubject devicePredicate | Reference predicate | ||||
|---|---|---|---|---|---|
| Device name | Cover Screw | Implantium(Cover Screw) | SimpleLine IIAbutment System(Cover Screw) | NR Line ImplantSystem(Cover Screw) | DentiumImplantium® andSuperLine®Abutments(Cover Screw) |
| Manufacturer | Dentium Co., Ltd. | Dentium Co., Ltd. | Dentium Co., Ltd. | Dentium Co., Ltd. | Dentium Co., Ltd. |
| 510(k) Number | K192436 | K052957 | K112045 | K153268 | K141457 |
| Indication foruse | DentiumProsthetics areintended for use asan aid inprostheticrehabilitation. | ImplantiumProsthetics isintended for use asan aid inprostheticrehabilitation. | The SimpleLine IIAbutment systemis intended for useas an aid inprostheticrehabilitation. | The NR LineImplants Systemis indicated for usein surgical andrestorativeapplications forplacement in thebone of theupper or lower jawto provide supportfor prostheticdevices, such asartificial teeth, inorder to restore thepatient'schewing function.NR Line ImplantSystem isindicated also forimmediate loadingwhen goodprimary stability isachieved and withappropriateocclusal loading. | DentiumProsthetics areintended for use asan aid inprostheticrehabilitation. |
| Materials | Ti-6Al-4V ELI(ASTM F136) | Ti-6Al-4V ELI(ASTM F136) | Ti-6Al-4V ELI(ASTM F136) | Ti-6Al-4V ELI(ASTM F136) | Ti-6Al-4V ELI(ASTM F136) |
| Form | Preformed | Preformed | Preformed | Preformed | Preformed |
| Sterilization | Sterile(GammaRadiation) | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
| Use | Prescription | Prescription | Prescription | Prescription | Prescription |
| Single Use Only | Yes | Yes | Yes | Yes | Yes |
510(k) Summary
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Dimension comparison
| Image | Dimension (mm) | ||
|---|---|---|---|
| Subject device(K192436) | Image: dental implant | Diameter | 3.18 / 3.37 / 4.12 |
| Length | 6.36 / 6.88 / 8.92 | ||
| Image: dental implant | Diameter | 3.10 / 3.50 | |
| Length | 4.70 / 5.70 | ||
| Image: dental implant | Diameter | 3.50 / 4.30 | |
| Length | 5.40 / 5.75 | ||
| Image: dental implant | Diameter | 3.55 | |
| Length | 6.35 | ||
| Predicate device | |||
| K052957 | Image: dental implant | Diameter | 3.18 / 3.37 / 4.12 |
| Length | 6.36 / 6.88 / 8.92 | ||
| K112045 | Image: dental implant | Diameter | 3.10 / 3.50 |
| Length | 4.70 / 5.70 | ||
| K153268 | Image: dental implant | Diameter | 3.50 / 4.30 |
| Length | 5.40 / 5.75 | ||
| K141457 | Image: dental implant | Diameter | 3.55 |
| Length | 6.35 |
1) Similarities
The subject Cover Screws have the same characteristics for the followings compared to the primary predicate device.
- Indication for use, Material, Dimension
The subject Cover Screws have the same dimensions cleared under K052957, K112045, K153268 and K141457.
2) Differences
The subject Cover Screws have the different characteristic for the following compared to the primary predicate device.
- Sterilization Method
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3) Discussion
The purpose of this submission is to change the sterilization method of Cover Screws previously cleared under K052957, K112045, K153268 and K141457. These Cover Screws which have been provided non-sterile will be sterilized by gamma radiation. In terms of sterilization method there is difference between the subject device and primary predicate device. However the sterilization method of subject device was validated according to ISO 111137-1 and ISO 11137-2, demonstrating a sterility assurance level (SAL) of 10-6.
In conclusion, the subject device is substantially equivalent to the predicate device because it is verified that the difference does not affect substantial equivalence.
8. Conclusion
Based on the information provided, the subject device is substantially equivalent to the predicate devices.
§ 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.)