(70 days)
HySil Heavy Plus is to be used as heavy-bodied materials for:
- One-step impression technique (simultaneous technique) using single or dual viscosities -
- Two-step impression technique using dual viscosities -
- Functional impressions -
HySil Mono Plus is to be used as a medium-bodied tray or syringeable impression material for:
- Taking impressions over fixed/removable restorations and implants -(i.e., transferring impressi on posts and bridge components)
- Functional impressions -
- Fabricating crown and bridgework or inlays -
- -Fabricating full or partial dentures
- Reline impressions -
- -Use in the simultaneous mixing technique as well as the putty-wash and triple tray techniques
- -Transferring root posts when fabricating posts and cores indirectly
HySil Light Plus is to be used as syringeable impression materials for:
- Two-step putty-wash impression technique -
- One-step putty-wash impression technique -
- Two-step impression technique using dual viscosities -
- Reline impressions -
- Fabricating full or partial dentures -
HySil Heavy Plus Auto is to be used as heavy-bodied materials for:
- One-step impression technique (simultaneous technique) using single or dual viscosities -
- Two-step impression technique using dual viscosities -
- Functional impressions -
HySil Heavy Plus, HySil Mono Plus, HySil Light Plus, HySil Heavy Plus Auto (hereinafter referred to as the"HySil Plus Impression Materials") meet ISO 4823 standard and consist of three different viscosities (heavy-bodied, medium-bodied, and light-bodied) in delivery system as standard 1:1 50ml cartridges automix cartridges, 5:1 380ml cartridges for use in most Auto-mix dispensing and mixing systems.
I am sorry, but the provided text does not contain information about a study proving a device meets acceptance criteria related to artificial intelligence (AI) performance in medical image analysis. The document is an FDA 510(k) premarket notification for "HySil Plus Impression Materials," which are dental impression materials.
The document discusses:
- The device's name, regulation number, classification, and product code.
- Indications for use for different viscosities of the impression materials.
- Comparison to predicate devices, focusing on material composition, standards conformed to (ISO 4823), working time, shelf-life, and principle of operation.
- Non-clinical performance testing, including biocompatibility (ISO 10993-1, 5, 10, 11), sterilization validation (not applicable as non-sterile), shelf-life determination, and mechanical properties (ISO 4823).
- A statement that "No clinical studies are submitted."
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI-powered device meets them, as this document is about a dental impression material and does not involve AI or medical image analysis.
{0}------------------------------------------------
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.
March 18, 2021
Osstem Implant Co., Ltd. % Peter Lee QA/RA Manager Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, Pennsylvania 19030
Re: K210041
Trade/Device Name: HySil Plus Impression Materials Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: January 19, 2021 Received: January 21, 2021
Dear Peter Lee:
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.
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
{1}------------------------------------------------
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 mediation-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,
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
510(k) Number: K210041
Device Name: HySil Plus Impression Materials
Indications for Use:
HySil Heavy Plus is to be used as heavy-bodied materials for:
- One-step impression technique (simultaneous technique) using single or dual viscosities -
- Two-step impression technique using dual viscosities -
- Functional impressions -
HySil Mono Plus is to be used as a medium-bodied tray or syringeable impression material for:
- Taking impressions over fixed/removable restorations and implants -(i.e., transferring impressi on posts and bridge components)
- Functional impressions -
- Fabricating crown and bridgework or inlays -
- -Fabricating full or partial dentures
- Reline impressions -
- -Use in the simultaneous mixing technique as well as the putty-wash and triple tray techniques
- -Transferring root posts when fabricating posts and cores indirectly
HySil Light Plus is to be used as syringeable impression materials for:
- Two-step putty-wash impression technique -
- One-step putty-wash impression technique -
- Two-step impression technique using dual viscosities -
- Reline impressions -
- Fabricating full or partial dentures -
HySil Heavy Plus Auto is to be used as heavy-bodied materials for:
- One-step impression technique (simultaneous technique) using single or dual viscosities -
- Two-step impression technique using dual viscosities -
- Functional impressions -
X Prescription Use (21 CFR 801 Subpart D)
Over-The Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
{3}------------------------------------------------
Osstem Implant Co., Ltd. 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com
510(k) Summary
Date: December 30, 2020
1. Company and Correspondent making the submission
| - | Submitter's Name | : Osstem Implant Co., Ltd. |
|---|---|---|
| - | Address | : 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan,48002, Republic of Korea |
| - | Contact | : Mr. Jinwoo Bae |
| - | Phone | : +82-51-850-2500 |
| - | Correspondent's Name | : Hiossen Inc. |
| - | Address | : 85 Ben Fairless Dr. Fairless Hills, PA 19030 |
| - | Contact | : Mr. Peter Lee |
| - | Phone | : +1-267-759-7031 |
2. Proposed Device
| - Trade or (Proprietary) Name | : HySil Plus Impression Materials |
|---|---|
| - Classification Name | : Impression Material |
| - Regulation Number | : 21CFR872.3660 |
| - Devce Classification | : Class II |
| - Classification Product Code | : ELW |
3. Predicated Device
- Primary Predicate -HySil Super Fast Impression Materials, Osstem Implant Co., Ltd. (K192941) HySil Heavy Plus Impression Materials, Osstem Implant Co., Ltd. (K181236)
4. Description
HySil Heavy Plus, HySil Mono Plus, HySil Light Plus, HySil Heavy Plus Auto (hereinafter referred to as the"HySil Plus Impression Materials") meet ISO 4823 standard and consist of three different viscosities (heavy-bodied, medium-bodied, and light-bodied) in delivery system as standard 1:1 50ml cartridges automix cartridges, 5:1 380ml cartridges for use in most Auto-mix dispensing and mixing systems.
{4}------------------------------------------------
Image /page/4/Picture/2 description: The image shows the logo and contact information for Osstem Implant Co., Ltd. The address is 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea. The telephone number is +82 51 850 2500, the fax number is +82 51 861 4693, and the website address is www.osstem.com.
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com
5. Substantial Equivalence Matrix
1) HySil Heavy, Mono, Light Plus
| Proposed Devices | Predicated Devices | Remark | DescriptionofMaterial | Vinylpolysiloxane | Vinylpolysiloxane | Compose withsame affiliatedmaterial, butratios of eachcomponent inuse aredifferent | |
|---|---|---|---|---|---|---|---|
| Device Name | HySil PlusImpression MaterialsHeavy, Mono, Light,Heavy Auto | HySil Super FastImpression MaterialsHeavy, Mono, Light | Different | StandardConformed | ISO 4823 | ISO 4823 | Same |
| 510(k) No. | K210041 | K192941 | Different | Working Time | Over 2 min. | Over 1 min. 15 sec. | Proposeddevices havelongerworking time |
| Manufacturer | Osstem Implant Co.,Ltd. | Osstem Implant Co.,Ltd. | Same | Shelf-life | 2 years | 2 years | Same |
| Indications forUse | HySil Heavy Plus is tobe used as heavy-bodiedmaterials for:- One-step impressiontechnique(simultaneoustechnique) usingsingle or dualviscosities- Two-step impressiontechnique using dualviscosities- FunctionalimpressionsHySil Mono Plus is tobe used as a medium-bodied tray orsyringeable impressionmaterial for:- Taking impressionsover fixed/removablerestorations andimplants(i.e., transferringimpression posts andbridge components)- Functionalimpressions- Fabricating crown andbridgework or inlays | HySil Heavy SuperFast is to be used asheavy-bodied materialsfor:- One-step impressiontechnique(simultaneoustechnique) usingsingle or dualviscosities- Two-step impressiontechnique using dualviscosities- FunctionalimpressionsHySil Mono SuperFast is to be used as amedium-bodied tray orsyringeable impressionmaterial for:- Taking impressionsover fixed/removablerestorations andimplants(i.e., transferringimpression posts andbridge components)- Functionalimpressions- Fabricating crown and | Same | CompatibleAccessories | Mixing TipOral TipDispenser Gun | Mixing TipOral TipDispenser Gun | Same |
| S.E. | SimilaritiesThe proposed devices and the predicated devices are made withsame affiliated material called Vinylpolysiloxane conformed to ISO4823 standard. HySil Heavy Plus/Mono Plus/Light Plus aredelivered in 50 ml catridge with base and catalyst ratio of 1 to 1;have same indications for use; have same principle of operation; andhave same shelf-life.DifferencesCompared to the predicated devices, the proposed devices havedifferent composition ratio and working time proposed frommanufacturer. However, the proposed and the predicated devicesboth meet the requirements in regard with performance andbiocompatibility test according to the ISO4823.Thus, the differences in composition rations and delivered type donot affect the substantial equivalence of proposed devices since theproposed products meet ISOTherefore, we stated that proposed devices (HySil Heavy Plus,Mono Plus, Light Plus) are substantially equivalent to thepredicated devices (HySil Heavy, Mono, Light Super FastImpression Materials) cleared in K192941 | ||||||
| - Fabricating full or- partial dentures- Reline impressions- Use in thesimultaneous mixingtechnique as well asthe putty-wash andtriple tray techniques- Transferring rootposts when fabricatingposts and coresindirectlyHySil Light Plus is tobe used as syringeableimpression materialsfor:- Two-step putty-washimpression technique- One-step putty-washimpression technique- Two-step impressiontechnique using dualviscosities- Reline impressions- Fabricating full orpartial dentures | - bridgework or inlays- Fabricating full orpartial dentures- Reline impressions- Use in thesimultaneous mixingtechnique as well asthe putty-wash andtriple tray techniques- Transferring rootposts when fabricatingposts and coresindirectlyHySil Light Super Fastis to be used assyringeable impressionmaterials for:- Two-step putty-washimpression technique- One-step putty-washimpression technique- Two-step impressiontechnique using dualviscosities- Reline impressions- Fabricating full orpartial dentures | ||||||
| Principle ofOperation | - Be placed on animpression tray (orinjected directly intothe mouth, dependingon the technique anddevice) and used toreproduce thestructure of a patient'steeth and gums- Provide models forstudy and forproduction ofrestorative prostheticdevices | - Be placed on animpression tray (orinjected directly intothe mouth, dependingon the technique anddevice) and used toreproduce thestructure of a patient'steeth and gums- Provide models forstudy and forproduction ofrestorative prostheticdevices | Same |
{5}------------------------------------------------
Image /page/5/Picture/2 description: The image contains the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a stylized font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, sans-serif font. 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 51 861 4693 www.osstem.com
{6}------------------------------------------------
Image /page/6/Picture/2 description: The image shows the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, sans-serif font. There is a small circle above and to the right of the word "OSSTEM".
Osstem Implant Co., , Ltd..
66-16, Bansong-ro 513beon-gil, Haeunda-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com
{7}------------------------------------------------
Image /page/7/Picture/2 description: The image contains the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a bold, sans-serif font, with a superscript circle containing the letter "O". Below the word "OSSTEM" is the word "IMPLANT" in a smaller, sans-serif font.
Osstem Implant Co., , Ltd..
66-16, Bansong-ro 513beon-gil, Haeunda-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com
2) HySil Heavy Plus Auto
| ProposedDevices | Predicated Devices | Remark | |||
|---|---|---|---|---|---|
| Device Name | HySil PlusImpressionMaterialsHeavy Plus Auto | HySilFastImpressionMaterialsHeavy | HySilImpressionMaterialsHeavy | Different | |
| 510(k) No. | K210041 | K192941 | K181236 | Different | |
| Manufacturer | Osstem ImplantCo., Ltd. | Osstem ImplantCo., Ltd. | Osstem ImplantCo., Ltd. | Same | |
| Indicationsfor Use | HySil HeavyPlus Auto is tobe used as heavy-bodied materialsfor:- One-stepimpressiontechnique(simultaneoustechnique)using single ordual viscosities- Two-stepimpressiontechnique usingdual viscosities- Functionalimpressions | HySil HeavySuper Fast is tobe used as heavy-bodied materialsfor:- One-stepimpressiontechnique(simultaneoustechnique)using single ordual viscosities- Two-stepimpressiontechnique usingdual viscosities- Functionalimpressions | HySil Heavy isto be used asheavy-bodiedmaterials for:- One-stepimpressiontechnique(simultaneoustechnique)using single ordual viscosities- Two-stepimpressiontechnique usingdual viscosities- Functionalimpressions | Same | |
| Principle ofOperation | Be placed onan impressiontray (orinjecteddirectly into themouth,depending onthe techniqueand device) andused toreproduce thestructure of apatient's teeth | Be placed onan impressiontray (orinjecteddirectly into themouth,depending onthe techniqueand device) andused toreproduce thestructure of apatient's teeth | Be placed onan impressiontray (orinjecteddirectly into themouth,depending onthe techniqueand device) andused toreproduce thestructure of apatient's teeth | Same | |
| and gums- Provide modelsfor study andfor productionof restorativeprostheticdevices | and gums- Provide modelsfor study andfor productionof restorativeprostheticdevices | and gums- Provide modelsfor study andfor productionof restorativeprostheticdevices | |||
| Description ofMaterial | Vinylpolysiloxane | Vinylpolysiloxane | Vinylpolysiloxane | Composewith sameaffiliatedmaterial,but ratiosof eachcomponentin use aredifferent | |
| StandardConformed | ISO 4823 | ISO 4823 | ISO 4823 | Same | |
| WorkingTime | Over 2 min. | Over 1 min.15 sec. | Over 2 min. | Same/Different | |
| Shelf-life | 2 years | 2 years | 2 years | Same | |
| CompatibleAccessories | Mixing TipAuto Mixer | Mixing TipOral TipDispenser Gun | Mixing TipAuto Mixer | Same/Different | |
| S.E. | SimilaritiesThe proposed devices and the predicated devices are made with sameaffiliated material called Vinylpolysiloxane conformed to ISO 4823standard. In addition, the proposed product has same indication for use,principle of operation and shelf-life.DifferencesCompared to the predicated devices, the proposed devices(HySil HeavyPlus auto) have different composition ratios, working time proposedfrom manufacturer and delivered type that is bulk type(automixcartridge version). In case of automix cartridge version, it has beendeveloped for user's convenience. Although, there are some differencessuch as composition ratios, working time and delivered type, theproposed and the predicated devices both meet the requirements inregard with performance and biocompatibility test according to theISO4823.Thus, the differences in composition rations and delivered type do not |
{8}------------------------------------------------
Image /page/8/Picture/2 description: The image shows the logo for Osstem Implant. The logo is in orange and features the word "OSSTEM" in a bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, sans-serif font. The logo is simple and modern.
OSStem Implant Co., ILtd.
66-16, Bansong-ro 513beon-gil, Haeunda-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com
{9}------------------------------------------------
)sstem Implant Co., Ltd
6, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com
affect the substantial equivalence of proposed device. A Therefore, we stated that proposed device (Heavy Plus Auto) is substantially equivalent to the predicated devices (HySil Heavy Super Fast Impression Materials) cleared in K192941.
6. Indications for Use
HySil Heavy Plus is to be used as heavy-bodied materials for:
- One-step impression technique (simultaneous technique) using single or dual viscosities
- Two-step impression technique using dual viscosities
- Functional impressions
HySil Mono Plus is to be used as a medium-bodied tray or syringeable impression material for:
- Taking impressions over fixed/removable restorations and implants (i.e., transferring impression posts and bridge components)
- Functional impressions
- Fabricating crown and bridgework or inlays
- Fabricating full or partial dentures
- Reline impressions
- Use in the simultaneous mixing technique as well as the putty-wash and triple tray techniques
- Transferring root posts when fabricating posts and cores indirectly
HySil Light Plus is to be used as syringeable impression materials for:
- Two-step putty-wash impression technique
- One-step putty-wash impression technique
- Two-step impression technique using dual viscosities
- Reline impressions
- Fabricating full or partial dentures
7. Summary of Non-clinical Performance Testing
Non-clinical testing data are submitted to demonstrate substantial equivalence.
Biocompatibility Evaluation
Biocompatibility testing was considered followed the FDA Guidance Document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process," and the ISO 10993-5, 10 and 11 including cytotoxicity, skin sensitization, oral mucosa irritation, and acute systemic toxicity test.
{10}------------------------------------------------
Osstem Implant Co., Ltd.
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com
Sterilization Validation and Shelf-life
Proposed devices are delivered in non-sterile. Therefore, sterilization was not considered. The Shelf-life testing was considered followed the FDA Guidance Document Shelf Life of Medical Device, ISO 4823; and determined shelf-life of proposed devices are 2 years.
Mechanical Properties
Mechanical testing was evaluated following ISO 4823 including visual, weight, package, component color, consistency, detail reproduction, compatibility with gypsum, linear dimensional change, elastic recovery, strain-in-compression, and working time, and it was found that the proposed devices are substantially equivalent to the predicate devices from the result of bench test.
8. Summary of Clnical Testing
No clinical studies are submitted.
9. Conclusion
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 HySil Plus Impression Materials are substantially equivalent to the predicated devices as herein.
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).