K Number

Device Name

Neodent Implant System - Helix Short Surgical Kit Cases

Manufacturer

JJGC Industria e Comercio de Materiais Dentarios S.A.

Date Cleared

2023-04-20

(135 days)

Product Code

KCT

Regulation Number

880.6850

Intended 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: 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 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K192670

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use clearly define the device as a reusable rigid container for organizing and sterilizing surgical instruments. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on sterilization, cleaning, and durability, not on any analytical or predictive capabilities.

Therapeutic

The device is described as an organizational and sterilization container for surgical instruments, not as a device that directly treats or diagnoses a medical condition or disease.

Diagnostic

No
The device, HS Surgical Kit Cases, is intended for the organization, sterilization, storage, and transport of surgical and/or prosthetic instruments. It is a reusable rigid container used to protect instruments and facilitate their sterilization. There is no mention of it being used to diagnose conditions or processes.

SaMD (Software as a Medical Device)

The device description clearly states it is a reusable rigid container made of autoclavable polymer with silicone grommets, indicating it is a physical hardware device.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is clearly stated as "organization of surgical and/or prosthetic instruments during sterilization. storage, and transport." and to "allow sterilization of the medical devices included." This relates to the handling and sterilization of surgical instruments, not the examination of specimens derived from the human body.
Device Description: The device is described as "reusable rigid containers" used to "organize and protect instruments and accessories that are to be sterilized." This aligns with a device used in a surgical setting for instrument management.
Lack of IVD Characteristics: There is no mention of:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a patient's health status, diagnosis, or treatment.
- Reagents, calibrators, or controls typically associated with IVD devices.

The device's function is purely related to the physical management and sterilization of surgical instruments.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

KCT

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Performance Data:

Custom Manual Cleaning Validation:
- Purpose: Manual cleaning validation using Blood Soil (BLSO).
- Acceptance Criteria: Visual inspection: No Visible Soil; Hemoglobin test:

Regulation Number and Section

§ 880.6850 Sterilization wrap.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

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

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

Indications for Use

510(k) Number (if known) K223662

Device Name

Neodent Implant System - Helix Short Surgical Kit Cases

Indications for Use (Describe)