Who is the manufacturer of Neodent Implant System - Helix Short Surgical Kit Cases?

Jjgc Industria E Comercio DE Materiais Dentarios S.A. filed the 510(k) submission for Neodent Implant System - Helix Short Surgical Kit Cases (K223662).

What is the FDA product code for Neodent Implant System - Helix Short Surgical Kit Cases?

KCT. It is classified under 21 CFR 880.6850 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for Neodent Implant System - Helix Short Surgical Kit Cases?

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

What are the predicate devices for Neodent Implant System - Helix Short Surgical Kit Cases?

Neodent Instrument Kit Cases (K192670).

Who can help prepare an FDA 510(k) submission like Neodent Implant System - Helix Short Surgical Kit Cases?

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.

Neodent Implant System - Helix Short Surgical Kit Cases

K223662 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · KCT · Apr 20, 2023 · General Hospital

Device Facts

Record ID	K223662
Device Name	Neodent Implant System - Helix Short Surgical Kit Cases
Applicant	Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Product Code	KCT · General Hospital
Decision Date	Apr 20, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6850
Device Class	Class 2

Indications for Use

The HS Surgical Kit Cases are indicated for the organization of surgical and/or prosthetic instruments during sterilization. storage, and transport. Use of this product facilitates the storage and organization of instruments during and after surgical procedures. Neodent instrument kit cases are intended to allow sterilization of the medical devices included. Neodent instrument kit cases must be wrapped in FDA-approved materials to maintain the sterility of the devices included. The kits should be placed in an FDA-approved sterilization wrap for the indicated cycles and sterilized by moist heat (steam) using one of the following cycles: sterilized by moist heat (steam) using one of the following cycles: Dynamic Air Removal (Pre-Vacuum): exposure at 132°C for 4 minutes, drying for 30 minutes. Gravity displacement: exposure at 132°C for 15 minutes, drying for 50 minutes. Neodent instrument kit cases are intended for sterilization of non-porous fillers. The combined weight of the HS Surgical Kit case and associated instruments is 302.88 grams. The weight of the empty case is approximately 214.85 grams. Neodent instrument kit cases should not be stacked during sterilization.

Device Story

Reusable rigid container system for dental surgical/prosthetic instruments; comprises polysulfone base, removable inner tray, polyphenylsulfone lid, and medical-grade silicone retention grommets. Used in clinical settings by healthcare providers to organize, protect, and sterilize instruments. Device is perforated to allow steam penetration. Healthcare provider places instruments in case, wraps in FDA-cleared material, and subjects to validated steam sterilization cycles (Gravity or Pre-Vacuum). Output is a sterile, organized kit for surgical use. Benefits include instrument protection, organized workflow, and maintained sterility during storage/transport.

Clinical Evidence

Bench testing only. Validated manual cleaning (blood soil removal, hemoglobin/protein residuals), sterilization efficacy (ANSI/AAMI/ISO 17665-1/2, SAL 10^-6), life cycle testing (100 cycles of cleaning/sterilization), and biocompatibility (ISO 10993-5 cytotoxicity). All tests passed.

Technological Characteristics

Materials: Polysulfone (base), polyphenylsulfone (lid), medical-grade silicone (grommets). Design: Perforated rigid container with removable tray. Energy: Moist heat (steam). Dimensions: 195 x 90 x 67 mm. Connectivity: None. Sterilization: Steam (Gravity/Pre-Vacuum). Software: None.

Indications for Use

Indicated for organization, storage, and transport of surgical/prosthetic instruments during and after procedures. Intended for use by healthcare providers to facilitate sterilization of non-porous fillers via moist heat (steam) cycles. Requires FDA-approved sterilization wrap. Contraindicated for stacking during sterilization.

Regulatory Classification

Identification

A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

Predicate Devices

Neodent Instrument Kit Cases (K192670)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. April 20, 2023 JJGC Industria e Comercio de Materiais Dentarios S.A. % Jennifer Jackson, Ms Sr. Director, Regulatory Affairs and Quality Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810 ### Re: K223662 Trade/Device Name: Neodent Implant System - Helix Short Surgical Kit Cases Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: March 13, 2023 Received: March 24, 2023 ### Dear Jennifer Jackson, 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 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 {1}------------------------------------------------ 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, Digitally signed Eileen by Eileen Cadel -Cadel -S Date: 2023.04.20 14:00:15 -04'00' for Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K223662 Device Name Neodent Implant System - Helix Short Surgical Kit Cases Indications for Use (Describe) The HS Surgical Kit Cases are indicated for the organization of surgical and/or prosthetic instruments during sterilization. storage, and transport. Use of this product facilitates the storage and organization of instruments during and after surgical procedures. Neodent instrument kit cases are intended to allow sterilization of the medical devices included. Neodent instrument kit cases must be wrapped in FDA-approved materials to maintain the sterility of the devices included. The kits should be placed in an FDA-approved sterilization wrap for the indicated cycles and sterilized by moist heat (steam) using one of the following cycles: sterilized by moist heat (steam) using one of the following cycles: Dynamic Air Removal (Pre-Vacuum): exposure at 132°C for 4 minutes, drying for Dynamic Air Removal (Pre-Vacuum): exposure at 132°C for 4 minutes, drying for 30 minutes. Gravity displacement: exposure at 132°C for 15 minutes, drying for 50 minutes. Neodent instrument kit cases are intended for sterilization of non-porous fillers. The combined weight of the HS Surgical Kit case and associated instruments is 302.88 grams. The weight of the empty case is approximately 214.85 grams. Neodent instrument kit cases should not be stacked during sterilization. | 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(K) Summary ## ADMINISTRATIVE INFORMATION | Sponsor | JJGC Indústria e Comércio de Materiais Dentários SA | | |---------------------------------|-----------------------------------------------------|--| | | (dba Neodent) | | | | Av. Juscelino Kubitschek de Oliveira, 3291 | | | | Curitiba, Parana, Brazil 81270-200 | | | | Registration No.: 3008261720 | | | | Owner/Operator No.: 10031702 | | | Contact Person | Jennifer M. Jackson, MS | | | | Director of Regulatory Affairs, | | | | Straumann USA | | | | E-mail: jennifer.jackson@straumann.com | | | | Telephone (978) 747-2509 | | | Date Prepared | 19/Apr/2023 | | | Preparer / Alternate Contact | Bárbara Uzae | | | | Regulatory Affairs Analyst | | | | JJGC Indústria e Comércio de Materiais Dentários SA | | | | E-mail: barbara.uzae@neodent.com | | ### DEVICE NAME AND CLASSIFICATION | Trade/ Proprietary Name | Neodent Implant System – Helix Short Surgical Kit Cases | |------------------------------|-----------------------------------------------------------------------------------------------| | Common Name | Instrument Sterilization Trays | | Classification Name | Sterilization Wrap Containers, Trays, Cassettes & Other | | Classification Regulations | 21 CFR 880.6850, Class II | | Product Code | KCT | | Classification Panel | General Hospital | | PREDICATE DEVICE INFORMATION | | | Primary Predicate Device | K19260 - Neodent Instrument Kit Cases, JJGC Indústria Comércio de Materiais Dentários S.A. | | Classification Name | Sterilization Wrap | e {4}------------------------------------------------ Classification Regulations 21 CFR 880.6850, Class II Product Code КСТ #### INDICATIONS FOR USE #### Indications for Use for Helix Short Surgical Kit Case and Helix Short Pre-Mounted Surgical Kit Case: The HS Complete Surgical Kit Cases are indicated for the organization of surgical and/or prosthetic instruments during sterilization, storage, and transport. Use of this product facilitates the storage and organization of instruments during and after surgical procedures. Neodent instrument kit cases are intended to allow sterilization of the medical devices included. Neodent instrument kit cases must be wrapped in FDA-approved materials to maintain the sterility of the devices included. The kits should be placed in an FDA-approved sterilization wrap for the indicated cycles and sterilized by moist heat (steam) using one of the following cycles: Dynamic Air Removal (Pre-Vacuum): exposure at 132°C for 4 minutes, drying for 30 minutes. Gravity displacement: exposure at 132°C for 15 minutes, drying for 50 minutes. Neodent instrument kit cases are intended for sterilization of non-porous fillers. The combined weight of the HS Surgical Kit case and associated instruments is 302.88 grams. The weight of the empty case is approximately 214.85 grams. Neodent instrument kit cases should not be stacked during sterilization. #### SUBJECT DEVICE DESCRIPTION The subject device kit cases are reusable rigid containers, comprising a case bottom (or base), a removable inner tray, and tray lid (lid). The subject device kits are to be used to organize and protect instruments and accessories that are to be sterilized by the healthcare provider. The subject kit cases are manufactured in autoclavable polymer. The design of the subject devices include grommets manufactured from medical grade silicone that retain the instruments within the tray. They also presents markings that guide instrument use during procedures. The subject device kit cases are provided nonsterile to the end-user. | Assembled Kit Case | Description | Assembled Kit Case Dimension (L x W x H) | Component Number | Component Dimension (L x W x H) | |-----------------------|----------------------------------------------|---------------------------------------------------|---------------------|---------------------------------------| | 110.317 | Helix Short Surgical Kit Case | 195 x 90 x 67 mm | 704637 (Lid) | 195 x 90 x 49 mm | | | | | 704636 (Tray) | 188 x 84 x 32 mm | | | | | 704635 (Base) | 180 x 76 x 27 mm | | 110.318 | Helix Short Pre-Mounted Surgical Kit Case | 195 x 90 x 67 mm | 704637 (Lid) | 195 x 90 x 49 mm | | | | | 704636 (Tray) | 188 x 84 x 32 mm | The dimensions for each part of the model and the overall dimensions are presented in the table below: {5}------------------------------------------------ | | | | 704635 (Base) | 180 x 76 x 27 mm | |--|--|--|---------------|------------------| |--|--|--|---------------|------------------| Note: The instrument and accessory devices that are sterilized and stored within the subject Kit Cases are not themselves subject devices of this submission. {6}------------------------------------------------ ### TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE | | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | K223662 Helix Short Surgical Kit Cases JJGC Indústria e Comércio de Materiais Dentários S.A. | K192670 Neodent Instrument Kit Cases JJGC Indústria e Comércio de Materiais Dentários S.A. | COMPARISON | | Indications for Use Statement | Indications for Use for Helix Short Surgical Kit Case and Helix Short Pre- Mounted Surgical Kit Case: The HS Complete Surgical Kit Cases are indicated for the organization of surgical and/or prosthetic instruments during sterilization, storage, and transport. Use of this product facilitates the storage and organization of instruments during and after surgical procedures. Neodent instrument kit cases are intended to allow sterilization of the medical devices included. Neodent instrument kit cases must be wrapped in FDA-approved materials to maintain the sterility of the devices included. The kits should be placed in an FDA-approved sterilization wrap for the indicated cycles and sterilized by moist heat (steam) using one of the following cycles: Dynamic Air Removal (Pre-Vacuum): exposure at 132°C for 4 minutes, drying for 30 minutes. Gravity displacement: exposure at 132°C for 15 minutes, drying for 50 minutes. Neodent instrument kit cases are intended for sterilization of non-porous fillers. The combined weight of the HS Surgical Kit case and associated instruments is 302.88 grams. The weight of the empty case is approximately 214.85 grams. Neodent instrument kit cases should not be stacked during sterilization. | Indications for Use for GM Surgical Kit Case: Neodent Instrument Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kit Cases require the use of FDA cleared wrap to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles: Dynamic Air Removal (Pre-Vacuum) – Exposure at 132 °C for 4 minutes, 20-minute dry time. Gravity displacement – Exposure at 132 °C for 15 minutes, 40-minute dry time. Neodent Instrument Kit Cases are intended for sterilization of non-porous loads. The combined weight of the GM Surgical Kit Case and the associated instruments is 613.1 g. The weight of the empty Kit Case is 510 grams. Neodent Instrument Kit Cases should not to be stacked during sterilization. Indications for Use for GM Helix Compact Surgical Kit Case: Neodent Instrument Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kit Cases require the use of FDA cleared wrap to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles: Dynamic Air Removal (Pre-Vacuum)- Exposure at 132 °C for 4 minutes, 20-minute dry time Gravity displacement – Exposure at 132 °C for 15 minutes, 20-minute dry time. Neodent Instrument Kit Cases are intended for sterilization of non-porous loads. The combined weight of the GM Helix Compact Surgical Kit Case and the associated instruments is 308.2 g. The weight of the empty Kit Case is 231 grams. Neodent Instrument Kit Cases should not to be stacked during sterilization. | Equivalent Although the language is slightly different, the indications for use are equivalent. Both Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. The difference in the text is specific due to the weight of each device in their maximum load configuration. | | | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | COMPARISON | | | K223662 Helix Short Surgical Kit Cases JJGC Indústria e Comércio de Materiais Dentários S.A. | K192670 Neodent Instrument Kit Cases JJGC Indústria e Comércio de Materiais Dentários S.A. | | | Intended Use | This product is used for safe storage and securing of instruments during sanitation, sterilization, and surgical procedures. | The GM Helix Compact Surgical Kit Case is suitable for safe storage of surgical and prosthetic instruments, organizing the instruments in the sequence in which they will be used, as well as for sterilization of such instruments. | Equivalent Subject and predicate device are intended to safe storage surgical instruments and provide support during sterilization. | | Design | Rigid polysulfone polymer base and removable inner tray with a polyphenylsulfone lid. Retention grommets of medical grade silicone. | Rigid polysulfone polymer base and removable inner tray with a polyphenylsulfone lid. Retention grommets of medical grade silicone. | Identical Subject and primary predicate devices have the same materials. | | Perforated | Yes; allows moist heat (steam) penetration to achieve sterilization. | Yes; allows moist heat (steam) penetration to achieve sterilization | Identical | | Reusable | Yes | Yes | Identical | | Overall dimensions | 110.317: 195 L x 90 W x 67 H, mm 110.318: 195 L x 90 W x 67 H, mm | 110.288: 264 L x 163 W x 54 H, mm 110.297: 195 L x 90 W x 64 H, mm | Similar Subject Kit Cases have the similar size to the article 110.297 of the predicate device. The small difference between than does not compromise safety and efficacy as is better discussed along | JJGC Indústria e Comércio de Materiais Dentários S.A. {7}------------------------------------------------ # Traditional 510(k) submission ### K223662 - Helix Short Surgical Kit Case {8}------------------------------------------------ ## Traditional 510(k) submission K223662 - Helix Short Surgical Kit Case | | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | | |-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | K223662 Helix Short Surgical Kit Cases JJGC Indústria e Comércio de Materiais Dentários S.A. | K192670 Neodent Instrument Kit Cases JJGC Indústria e Comércio de Materiais Dentários S.A. | COMPARISON | | Volume to Vent Ratio | $110.317: 64.8 cm³/ cm² (25.5 in³/in²)$ $110.318: 64.8 cm³/ cm² (25.5 in³/ in²)$ | $110.288: 98.04 cm³/cm² (38.6 in³/ in²)$ $110.297: 63.5 cm³/cm² (25.0 in³/ in²)$ | Equivalent The primary predicate devices (110.297) have volume to vent ratio slightly bigger than the subject devices. The small difference between than does not compromise safety and efficacy, as is proved by the presented sterilization validation. | | Life cycle | Reusable up to 100 cycles | Reusable up to 100 cycles | Identical | | Biocompatibility | The assessment to Biocompatibility was performed per ISO 10993-1 and testing was performed using methods described in AAMI/ANSI/ISO 10993-5. The results indicate that the subject devices are biocompatible. | The assessment to Biocompatibility was performed per ISO 10993-1 and testing was performed using methods described in AAMI/ANSI/ISO 10993-5. The results indicate that the subject devices are biocompatible. | Equivalent | | Sterilization Method | Moist heat (steam) to a SAL of 10-6 | Moist heat (steam) to a SAL of 10-6 | Identical | | Cycles | Gravity displacement Dynamic Air Removal (Pre-Vacuum) | Gravity displacement Dynamic Air Removal (Pre-Vacuum) | Identical | {9}------------------------------------------------ ### Traditional 510(k) submission #### K223662 - Helix Short Surgical Kit Case | | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | | | |-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|--| | | K223662 Helix Short Surgical Kit Cases JJGC Indústria e Comércio de Materiais Dentários S.A. | K192670 Neodent Instrument Kit Cases JJGC Indústria e Comércio de Materiais Dentários S.A. | COMPARISON | | | Parameters | Gravity Sterilization temperature: 132 °C; Sterilization time: 15 minutes; Drying time: 50 minutes. Dynamic Air Removal (Pre-Vacuum) Sterilization temperature: 132 °C; Sterilization time: 4 minutes; Drying time: 30 minutes. | Gravity Sterilization temperature: 132 °C Sterilization time: 15 minutes; Drying time: 40 minutes (model number 110.288) or 20 minutes (model number 110.297) Dynamic Air Removal (Pre-Vacuum) Sterilization temperature: 132 °C Sterilization time: 4 minutes; Drying time: 20 minutes. | Equivalent The subject devices have the same cycle parameters already cleared for the predicate devices. | | | Sterile Barrier | Sterilization wrap, FDA-cleared for indicated method and cycles | Sterilization pouch, FDA-cleared for indicated method and cycles | Identical | | {10}------------------------------------------------ The subject devices and the primary predicate devices cleared per K192670 have similar intended use and equivalent Indications for Use Statements. Both are reusable rigid containers used to organize and protect dental surgical instruments that are sterilized by the healthcare provider. The subject device and primary predicate device components are perforated to allow for penetration of the moist heat (steam) sterilant and require the use of an FDA-cleared wrap or pouch to maintain sterility. The subject devices and primary predicate device include components manufactured from polyphenylsulfone and polysulfone. The subject devices have the same size, whereas the primary predicate device is provided in two different size and configurations. The overall dimensions of the subject device are similar to the range of overall dimensions cleared for the predicate devices. The subject device and the primary predicate device are manufactured from materials with a history biocompatibility and clinical use for the cleared indications. The subject device and the predicate devices are to be used according to the validated labeling (sterilization processes and cycles). | Standard or Test Method | Purpose of the Testing | Acceptance Criteria | Results | |----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Custom | Manual cleaning validation Test Soil: Blood Soil (BLSO) Cleaning Method: Manual Residuals Tested: Hemoglobin and Protein | Visual Inspection: No Visible Soil Hemoglobin Test: <2.2 µg/cm2 Protein Test: <6.4 µg/cm2 | Passed | | ANSI/AAMI/ISO 17665-1 ANSI/AAMI/ISO 17665-2 | Sterilization validation, including sterilant penetration and drying time | All Biological Indicators must be incubated for at least 7 days at 55-60°C. All positive controls for SAL testing must show characteristic growth of the indicator organism. | Passed | | Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff | Life cycle (simulate usage) testing | The tested samples must withstand 100 cycles of use (cleaning, sterilization and functional tests) without compromising their functionalities | Passed | #### NON-CLINICAL PERFORMANCE DATA {11}------------------------------------------------ | ANSI/AAMI/ISO 10993-5 (Cytotoxicity) | Cytotoxicity testing | Less than 30% cell proliferation inhibition | Passed | |-----------------------------------------|----------------------|------------------------------------------------|--------| |-----------------------------------------|----------------------|------------------------------------------------|--------| #### CONCLUSION The subject devices and the primary predicate device have equivalent instructions for use, intended use, design and technological characteristics. They also present equivalent range of overall dimensions and same sterilization method. The conclusions drawn from the non-clinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the predicate device K192670.

Neodent Implant System - Helix Short Surgical Kit Cases

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

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Neodent Implant System - Helix Short Surgical Kit Cases

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

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