The Dentalhitec QuickSleeper 5 (QS5) is indicated for the administration of local anesthesia for dental procedures using computer-controlled handpiece and wireless foot pedal. The QuickSleeper5 is a reusable injection device, allowing intraosseous and mucosal injection of anesthetic within the oral cavity. The QS5 functionality includes injection, aspiration, and rotation. The handheld syringe device's electronic interface provides the user with information on selected injection speed and injection site resistance. The rotational movement allows the needle to pass through dense tissue.

AI/ML Overview

The provided FDA 510(k) clearance letter for the QuickSleeper 5 device indicates that it is a spring-powered jet injector for administering local anesthesia in dental procedures. The document primarily focuses on demonstrating substantial equivalence to a predicate device (RA-5 ANESTO Handpiece) and a reference device (The WAND STA System) through a comparison of technological characteristics and non-clinical performance testing.

However, the provided text does not contain the detailed acceptance criteria and study data typically associated with proving the AI/software component of a device meets specific performance metrics. The document mentions "Software Verification testing" as one of the non-clinical tests performed, but it only lists the categories of tests (Injection testing, Audio indicators, Option selection, Standby function, Conformance to IEC 62304) without providing:

Specific quantitative acceptance criteria (e.g., "injection volume must be within X% of target").
Reported device performance values against those criteria.
Details on the test set, data provenance, ground truth establishment, or human expert involvement often seen in AI/software clinical validation studies.
Any information about training sets for an AI system.

This suggests that the QuickSleeper 5, while having "computer-controlled" elements and "firmware with programmable settings," is being cleared as a mechanical/electronic device for drug delivery, not as a device heavily reliant on AI for diagnostic or decision-making purposes that would necessitate the kind of rigorous AI/ML performance validation outlined in your request. The "Software Verification testing" appears to relate more to functional safety and performance of the device's control software rather than a sophisticated AI algorithm making "decisions."

Therefore, based solely on the provided text, I cannot complete most of the requested fields because the information is not present. The document focuses on showing the device functions as intended mechanically and electronically and is safe and effective when used by a human practitioner, rather than demonstrating complex AI performance.

For completeness, I will extract what little information is available related to "acceptance criteria" and "study" details, while noting the significant gaps.

Acceptance Criteria and Reported Device Performance

The document states, "To demonstrate substantial equivalence, the subject device met the acceptance criteria for the following non-clinical testing." While it lists categories of tests, it does not provide specific quantitative acceptance criteria or the reported performance metrics of the device against those criteria.

Specific Acceptance Criterion (Quantiative)	Reported Device Performance
Not specified in provided text	Not specified in provided text
Examples of implied tests:
- Injection accuracy/volume	Not provided
- Audio indicator functionality	Not provided
- Option selection functionality	Not provided
- Standby function behavior	Not provided
- Conformance to IEC 62304 (Software lifecycle)	Confirmed conformance is stated
- Handpiece dimensions	Not provided
- Injection and perforation performance	Confirmed "met acceptance criteria"
- Assembly (component connections)	Confirmed "met acceptance criteria"
- Cleaning, disinfection, sterilization validations	Confirmed "met acceptance criteria"
- Biocompatibility	Confirmed "met acceptance criteria"
- Electrical safety (IEC 60601-1, etc.)	Confirmed "demonstrated effectiveness"

Study Details (Based on provided text)

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not specified. The document refers to "non-clinical testing" and "simulated use" but does not provide specific sample sizes (e.g., number of injections, number of test runs, number of users in usability).
- Data Provenance: Not specified. The manufacturer is Dentalhitec, located in France. The testing location or data origin is not mentioned. The studies were "non-clinical" and "simulated use," implying lab/bench testing rather than patient data.
- Retrospective or Prospective: N/A for this type of non-clinical, simulated use testing.
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/not specified. For "Software Verification testing" and "Device safety and performance testing" of a mechanical/electronic device, ground truth is typically established by engineering specifications, calibration standards, and established test methodologies, not human expert consensus. Usability testing involved "collecting user feedback through direct input and observations," implying users (dental professionals) participated, but details on their number or qualifications as "ground truth experts" are not given.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/not specified. Adjudication methods are typically used when subjective expert review is required to establish ground truth for complex tasks like image interpretation, which is not the primary subject of these tests.
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:
- No MRMC study was described. This is expected given the device's function as a drug delivery system, not an AI diagnostic/interpretive tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of an "AI" algorithm as you might expect for an image analysis tool. The "Software Verification testing" would implicitly include standalone algorithm (firmware) performance checks, but these are for the control functions of the device (injection, audio, etc.), not for an independent AI diagnostic output.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For functional and safety testing, ground truth is based on engineering specifications, physical/electrical measurements, established industry standards (e.g., ISO, IEC), and successful completion of pre-defined test protocols. It is not derived from expert consensus, pathology, or outcomes data in the way an AI diagnostic would require.
The sample size for the training set:
- Not applicable/not specified. The document does not describe the use of machine learning or AI that would require a "training set" in the conventional sense. The "firmware" likely contains programmed logic and presets, not a model trained on data.
How the ground truth for the training set was established:
- Not applicable. No training set for an AI model is described.

Summary of Limitations Based on Provided Text:

The provided FDA letter and 510(k) summary are for a medical device (spring-powered jet injector) with some electronic and software controls, but it does not represent a typical AI/ML-driven device that would require validation against complex "ground truth" derived from patient data or human expert interpretation. The "software verification testing" mentioned refers to the functional software controlling the mechanical aspects of the device, not an AI algorithm performing complex analytical tasks. Therefore, most of the detailed information requested for an AI system's validation is not present in this document.

Summary

FDA 510(k) Clearance Letter - QuickSleeper 5

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

August 1, 2025

Dentalhitec
℅ Adrienne Von Foller
Consultant
QRS Solutions LLC
966 E. 2050 N
Ogden, Utah 84414

Re: K243427
Trade/Device Name: QuickSleeper 5
Regulation Number: 21 CFR 872.4475
Regulation Name: Spring-Powered Jet Injector
Regulatory Class: Class II
Product Code: EGM, EJI
Dated: October 7, 2024
Received: November 5, 2024

Dear Adrienne Von Foller:

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 (the 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 available 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.

FDA U.S. FOOD & DRUG ADMINISTRATION

August 1, 2025

Dentalhitec
℅ Adrienne Von Foller
Consultant
QRS Solutions LLC
966 E. 2050 N
Ogden, Utah 84414

Dear Adrienne Von Foller:

U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K243427 - Adrienne Von Foller Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

Page 3

K243427 - Adrienne Von Foller Page 3

assistance/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 -S

Michael E. Adjodha, MChE, RAC, CQIA
Assistant Director
DHT1B: Division of Dental and
ENT Devices
OHT1: Office of Ophthalmic, Anesthesia,
Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Indications for Use

Submission Number (if known)
K243427

Device Name
QuickSleeper 5

Indications for Use (Describe)
Administration of local anesthesia for dental procedures.

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)

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."

Page 5

K243427 - 510(k) Summary

Page 1 of 4

Name of 510(k) Owner: Dentalhitec

Address of Submitter: Rue De Champs Blanc
Mazieres En Mauges
Maine-Et-Loire, France 49280

Submitter Contact: Olivier Villette,
General Manager / CEO

Prepared by (for contact): Adrienne von Foller
Regulatory Affairs Consultant
QRS Solutions, LLC
Telephone: (801) 916-8188
Email: AVonFoller@qrssolutionsllc.com

Date Prepared: July 29, 2025

Submission Type: Traditional 510(k)

Proprietary Name: QuickSleeper 5

Common Name(s): Injector, Jet, Mechanical-Powered

Classification: 21 CFR 872.4475, Spring-powered jet injector

Device Class: Class II

Device Product Code: EGM, EJI

Predicate Device: K083811 – RA-5 ANESTO Handpiece

Reference Device: K061904 – The WAND STA System

Device Description

Indications for Use

Administration of local anesthesia for dental procedures.

Page 6

K243427 - 510(k) Summary

Name of 510(k) Owner: Dentalhitec

Address of Submitter: Rue De Champs Blanc
Mazieres En Mauges
Maine-Et-Loire, France 49280

Submitter Contact: Olivier Villette,
General Manager / CEO

Prepared by (for contact): Adrienne von Foller
Regulatory Affairs Consultant
QRS Solutions, LLC
Telephone: (801) 916-8188
Email: AVonFoller@qrssolutionsllc.com

Date Prepared: July 29, 2025

Submission Type: Traditional 510(k)

Proprietary Name: QuickSleeper 5

Common Name(s): Injector, Jet, Mechanical-Powered

Classification: 21 CFR 872.4475, Spring-powered jet injector

Device Class: Class II

Device Product Code: EGM, EJI

Predicate Device: K083811 – RA-5 ANESTO Handpiece

Reference Device: K061904 – The WAND STA System

Device Description

Indications for Use

Administration of local anesthesia for dental procedures.

Page 1 of 4

Page 7

K243427 - 510(k) Summary

Page 2 of 4

Technological Characteristics

The electronic motor of the QuickSleeper 5 system provides control over the delivery of anesthetic, with adjustable speed and pressure settings that allow the practitioner to optimize the injection process based on the specific needs of the procedure. It also includes an intraosseous setting, which enables rotational movement of the needle for bone penetration.

The ergonomic handpiece is designed with a "pen-like" grip. The system features both audible and visual indicators to provide real-time feedback to the practitioner. It is compatible with the manufacturer's needles and accommodates standard anesthetic cartridges of 1.7 mL and 1.8 mL sizes compatible with ISO 11499.

The system is equipped with a wireless foot pedal, handpiece mount, and handpiece stand. The control box includes firmware which includes programmable settings as well as basic presets that allow for varying injection techniques based on the specific needs of the procedure.

Substantial Equivalence

This candidate device, QuickSleeper 5, and predicate device are substantially equivalent and have the same intended use. Technological and performance differences do not raise any new questions of safety or effectiveness. Differences in technological characteristics between the QuickSleeper 5 and the predicate device do not affect substantial equivalence, including computer-controlled delivery of anesthesia, wireless foot pedal, and user interface elements. Additionally, a reference device has been included to provide a comparison of the similarities in technological characteristics to a legally marketed computer-controlled device. Comparison analysis of these devices are presented in the table below.

	Candidate Device	Predicate Device	Reference Device
Trade Name	QuickSleeper 5	RA-5 ANESTO Handpiece	The WAND STA System
Manufacturer	Dentalhitec	W&H Dentalwerk	Milestone Scientific, Spintech LLC
510(k) Number	K243427	K083811	K061904
Regulation	21 CFR 872.4475 Spring-powdered jet injector	21 CFR 872.4475 Spring-powdered jet injector	21 CFR 872.6770 Cartridge, Syringe
FDA Product Code	EGM, EJI	EGM	EJI
Classification	Class II	Class II	Class II – 510(k) Exempt
Intended Use	Local anesthesia injection in dentistry	Local anesthesia injection in dentistry	Local anesthesia injection in dentistry

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K243427 - 510(k) Summary

Technological Characteristics

Substantial Equivalence

	Candidate Device	Predicate Device	Reference Device
Trade Name	QuickSleeper 5	RA-5 ANESTO Handpiece	The WAND STA System
Manufacturer	Dentalhitec	W&H Dentalwerk	Milestone Scientific, Spintech LLC
510(k) Number	K243427	K083811	K061904
Regulation	21 CFR 872.4475 Spring-powdered jet injector	21 CFR 872.4475 Spring-powdered jet injector	21 CFR 872.6770 Cartridge, Syringe
FDA Product Code	EGM, EJI	EGM	EJI
Classification	Class II	Class II	Class II – 510(k) Exempt
Intended Use	Local anesthesia injection in dentistry	Local anesthesia injection in dentistry	Local anesthesia injection in dentistry

Page 2 of 4

Page 9

K243427 - 510(k) Summary

Page 3 of 4

	Candidate Device	Predicate Device	Reference Device
Indications for Use	Administration of local anesthesia for dental procedures	Drilling system to perforate cortical bone in order to administer local anesthesia in spongiosa. Application in dentistry.	To inject local anesthetic agents subcutaneously or intramuscularly for dental applications
Prescription Use?	Rx Only	Rx Only	Rx Only
Target Patient Population	Adult and pediatric (4 years old and older)	Adult and pediatric	Adult and pediatric
Use Environment	Professional healthcare facility	Professional healthcare facility	Professional healthcare facility
Mode of Action	Needle Placement • Needle rotation is used for intraosseous access. • Needle is placed through mucosa next to bone. Needle Rotation • Foot-controlled needle operation (motorized in handpiece) Injection • Drive Screw creates forward translation of plunger which transmits movement into the anesthetic cartridge. • Injection Modes: The anesthetic within the cartridge is ejected through the needle at the end of the container through one of three injection modes: Hi, IO or Lo. Aspiration • Computer controls allow for regulation of aspiration via foot pedal	Needle Placement • Needle rotation is used for intraosseous access. • Needle is placed through mucosa next to bone Needle Rotation • Separate air driven and electrical dental motors with maximum speed 2Ncm of torque rotates and drills through bone. Injection • Anesthetic is manually injected by repeatedly pressing the dosage lever.	Needle Placement • Needle is placed based on procedure being performed. Injection • Foot pedal controls injection flow rate (slight vs. modest pressure) • Computer controls allow for regulation of flow rates and pressure during injection Aspiration • Computer controls allow for regulation of aspiration via foot pedal
Power Source	Alternating power source providing 100-240 V	Powered by separate dental motor	Alternating power source providing 100-240 V
Compatible Accessories	- Effitec single-use needles (30G 9mm, 30G 16mm, 27G 35mm) only - Dental anesthetic cartridge (ISO 11499 compatible)	- W&H applicable, single-use injection needles - Dental anesthetic cartridge (ISO 11499 compatible)	Anesthetic capsules

Page 10

K243427 - 510(k) Summary

	Candidate Device	Predicate Device	Reference Device
Indications for Use	Administration of local anesthesia for dental procedures	Drilling system to perforate cortical bone in order to administer local anesthesia in spongiosa. Application in dentistry.	To inject local anesthetic agents subcutaneously or intramuscularly for dental applications
Prescription Use?	Rx Only	Rx Only	Rx Only
Target Patient Population	Adult and pediatric (4 years old and older)	Adult and pediatric	Adult and pediatric
Use Environment	Professional healthcare facility	Professional healthcare facility	Professional healthcare facility
Mode of Action	Needle Placement • Needle rotation is used for intraosseous access. • Needle is placed through mucosa next to bone. Needle Rotation • Foot-controlled needle operation (motorized in handpiece) Injection • Drive Screw creates forward translation of plunger which transmits movement into the anesthetic cartridge. • Injection Modes: The anesthetic within the cartridge is ejected through the needle at the end of the container through one of three injection modes: Hi, IO or Lo. Aspiration • Computer controls allow for regulation of aspiration via foot pedal	Needle Placement • Needle rotation is used for intraosseous access. • Needle is placed through mucosa next to bone Needle Rotation • Separate air driven and electrical dental motors with maximum speed 2Ncm of torque rotates and drills through bone. Injection • Anesthetic is manually injected by repeatedly pressing the dosage lever.	Needle Placement • Needle is placed based on procedure being performed. Injection • Foot pedal controls injection flow rate (slight vs. modest pressure) • Computer controls allow for regulation of flow rates and pressure during injection Aspiration • Computer controls allow for regulation of aspiration via foot pedal
Power Source	Alternating power source providing 100-240 V	Powered by separate dental motor	Alternating power source providing 100-240 V
Compatible Accessories	- Effitec single-use needles (30G 9mm, 30G 16mm, 27G 35mm) only - Dental anesthetic cartridge (ISO 11499 compatible)	- W&H applicable, single-use injection needles - Dental anesthetic cartridge (ISO 11499 compatible)	Anesthetic capsules

Page 3 of 4

Page 11

K243427 - 510(k) Summary

Discussion of Non-Clinical Tests Performed

To demonstrate substantial equivalence, the subject device met the acceptance criteria for the following non-clinical testing.

Software Verification testing including:

Injection testing
Audio indicators
Option selection
Standby function
Conformance to IEC 62304

Device safety and performance testing including:

Handpiece dimensions
Injection and perforation performance
Assembly (component connections)
Cleaning, disinfection, and sterilization validations
Biocompatibility

The electrical safety and effectiveness of the QuickSleeper 5 have been demonstrated through testing conducted in accordance with the following standards:

IEC 60601-1
IEC 60601-1-2
IEC 60601-4-2
IEC 60601-1-6

Discussion of Usability Testing

To evaluate the usability of the QuickSleeper 5 system, a comprehensive simulated use approach was taken which involved analyzing various aspects of user interaction. This included a detailed examination of user tasks and goals and collecting user feedback through direct input and observations.

Conclusion

Based on the comprehensive information and data provided in this submission, we conclude that the QuickSleeper 5 is substantially equivalent to the predicate device. Based on similar indications for use, technological characteristics, and non-clinical performance testing, the QuickSleeper 5 demonstrates substantial equivalence to the predicate device.

Page 4 of 4

Page 12

K243427 - 510(k) Summary

Discussion of Non-Clinical Tests Performed

To demonstrate substantial equivalence, the subject device met the acceptance criteria for the following non-clinical testing.

Software Verification testing including:

Injection testing
Audio indicators
Option selection
Standby function
Conformance to IEC 62304

Device safety and performance testing including:

Handpiece dimensions
Injection and perforation performance
Assembly (component connections)
Cleaning, disinfection, and sterilization validations
Biocompatibility

The electrical safety and effectiveness of the QuickSleeper 5 have been demonstrated through testing conducted in accordance with the following standards:

IEC 60601-1
IEC 60601-1-2
IEC 60601-4-2
IEC 60601-1-6

Discussion of Usability Testing

Conclusion

Page 4 of 4

Regulation Number and Section

§ 872.4475 Spring-powered jet injector.

(a)
Identification. A spring-powered jet injector is a syringe device intended to administer a local anesthetic. The syringe is powered by a spring mechanism which provides the pressure to force the anesthetic out of the syringe.(b)
Classification. Class II.