(179 days)
Not Found
No
The description focuses on the mechanical functions of drilling and injection, with no mention of AI or ML capabilities for decision-making, analysis, or automation beyond basic motor control.
No.
A therapeutic device is one that treats a disease or condition. This device is used to administer anesthesia for dental procedures, which is a diagnostic or procedural aid, not a treatment itself.
No
The device description indicates its purpose is for administering intraosseous anesthesia, which is a treatment function, not a diagnostic one.
No
The device description clearly outlines a physical device with mechanical components (drill, needle, motor, foot-pedal) that performs a physical action (drilling and injection). It is not solely software.
Based on the provided information, the Cyberjet™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This includes reagents, calibrators, control materials, kits, instruments, apparatus, equipment, or systems.
- Cyberjet™ Function: The Cyberjet™ is a device used for the administration of a substance (local anesthetic) directly into the bone for the purpose of numbing a tooth. It is a surgical/procedural device, not a device that analyzes biological specimens.
- Intended Use: The intended use is for "Administration of intraosseous anesthesia for dental indications," which is a therapeutic/procedural application, not a diagnostic one.
Therefore, the Cyberjet™ falls under the category of a surgical or procedural device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
- Administration of intraosseous anesthesia for dental indications.
Product codes (comma separated list FDA assigned to the subject device)
76DZM, 76EKX, 76EGH
Device Description
The Cyberjet™ is a dental device intended for intraosseous injection of local anesthetics. Intraosseous injection of local anesthetics is a long-standing technique in dental anesthesia that was developed in the early 1900's and is still in common use in dental anesthesia today. Intraosseous injection requires the dentist to drill a small hole in the bone adjacent to the problem tooth. The dentist then uses a standard anesthesia needle and svringe to inject the local anesthetic solution into the previously drilled hole to numb the nerve of the tooth.
The Cyberjet™ combines the dental drill and the injection needle into one device and performs both the drilling and injection functions with the same device. After an appropriate injection site has been identified, a topical anesthetic is applied to the gum, followed by a few minutes wait to allow the topical anesthetic to take effect.
The previously selected injection site is located and the injection motor and the injection motor are turned on. The tip of the drill/needle is placed on the overlying gum and pressure is applied. The drill/needle passes through the soft tissue and starts to perforate the cortical plate. After the penetration of the cortical plate, the drill motor is turned off by releasing the momentary-switch on the foot-pedal. Local anesthetic is continuously dispensed into the tissue during and after the drilling process through the Infuser. Use of the Cyberjet™ will result in a simple one-step intraosseous injection for dental anesthesia.
The system includes 5 components:
-
- A Hollow Tubing Needle referred to as a drill/needle or Infuser that serves as a drill as well as a hypodermic iniection needle.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
K9644802
MAY 27 1997
Appendix V Summary of Safety and Effectiveness Information
1
Section 510(k) Premarket Notification Summary of Safety and Effectiveness Information Cyberjet™ Local Anesthesia System
Image /page/1/Picture/1 description: The image shows the logo for Cyberdent, Inc. The logo consists of a stylized atom symbol enclosed within a crescent shape. The text "CYBERDENT, INC." is located to the right of the symbol. The text is in a sans-serif font and is all capitalized.
Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92
- Device Trade Name: Cyberjet™ Local Anesthesia System
Common Name(s): Local Anesthesia System for Intraosseous Injection
Classification Name(s):
- Dental Injecting Needle 1.
-
- Handpiece, Direct Drive, AC-Powered
- ന് Injector, Jet, Mechanical-Powered
2. Establishment Name & Registration Number:
Name: CYBERDENT, INC.
Number: Pending
-
- Classification:
-
- § 872.4730 Dental injecting needle. (a) Identification. A dental injecting needle is a slender, hollow metal device with a sharp point intended to be attached to a syringe to inject local anesthetics and other drugs. (b) Classification. Class I.
-
- § 872.4200 Dental handpiece and accessories. (a) Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contraangle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth. (b) Classification. Class I. [55 FR 48439, Nov. 20, 1990]
-
- § 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.
Product Code(s):
- 76DZM 1.
-
- 76EKX
- నే. 76EGH
Device Class:
-
- 76DZM Class I
-
- 76EKX Class I
- ന് 76EGH - Class II
2
Classification Panel:
-
- Dental Devices Panel
-
- Dental Devices Panel
- ന Dental Devices Panel
4. Applicant / Sponsor Name / Address:
CYBERDENT, INC. 354 Bel Marin Kevs, Suite I Novato, CA 94949 415.883.0484 415.883.3037 - fax
5. Contact Person:
Mr. Gin Wu, Ph.D. CYBERDENT, INC. 354 Bel Marin Keys, Suite I Novato, CA 94949 415,883.0484 415.883.3037 - fax
-
- Equivalent / Predicate Device(s):
-
- Stabident System Intraosseous Local Anesthesia K910446
7. Description of the Device:
Introduction. The Cyberjet™ is a dental device intended for intraosseous injection of local anesthetics. Intraosseous injection of local anesthetics is a long-standing technique in dental anesthesia that was developed in the early 1900's and is still in common use in dental anesthesia today. Intraosseous injection requires the dentist to drill a small hole in the bone adjacent to the problem tooth. The dentist then uses a standard anesthesia needle and svringe to inject the local anesthetic solution into the previously drilled hole to numb the nerve of the tooth.
The Cyberjet™ combines the dental drill and the injection needle into one device and performs both the drilling and injection functions with the same device. After an appropriate injection site has been identified, a topical anesthetic is applied to the gum, followed by a few minutes wait to allow the topical anesthetic to take effect.
The previously selected injection site is located and the injection motor and the injection motor are turned on. The tip of the drill/needle is placed on the overlying gum and pressure is applied. The drill/needle passes through the soft tissue and starts to perforate the cortical plate. After the penetration of the cortical plate, the drill motor is turned off by releasing the momentary-switch on the foot-pedal. Local anesthetic is continuously dispensed into the tissue during and after the drilling process through the Infuser. Use of the Cyberjet™ will result in a simple one-step intraosseous injection for dental anesthesia.
The system includes 5 components:
-
- A Hollow Tubing Needle referred to as a drill/needle or Infuser that serves as a drill as well as a hypodermic iniection needle.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight. The logo is rendered in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 27 1997
Cyberdent, Incorporated C/O Mr. David W. Schlerf Buckman Company, Incorporated 1000 Burnett Avenue, Suite 450 Concord, California 94520
K964802 Re : Cyberjet™ Local Anesthesia System Trade Name: Requlatory Class: I Product Code: DZM Dated: February 26, 1997 February 27, 1997 Received:
Dear Mr. Schlerf:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉੱ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
4
Page 2 - Mr. Schlerf
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed- ---predicate device results in a classification for your device and thus, permits your device to proceed to the market. enab, Dezmire four advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) Additionally, for questions on the promotion and 594-4692. advertising of your device, please contact the Office of Compliance Also, please note the regulation entitled, at (301) 594-4639. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at (301) 443-6597 or at its its toll-free number (800) 638-2041 q internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
K. Wlatowski
A Ulatowski Time Director
Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page 1 of __ of __ 1
| 510(k) Number (if known): | K964802 |
|---|---|
| Device Name: | CYBERJET LOCAL ANESTHESIA SYSTEM |
| Indications For Use: |
- Administration of intraosseous anesthesia for dental indications. 1.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) AACam Division of Dental, Infection and General Hospital ાત્ર 510(k) Number _ Prescription Use Over-The-Counter Use OR (Per 21 CFR 801.109) (Optional format 1-2-96)