(87 days)
Not Found
Not Found
No
The summary describes a surgical drill with a specific coating and design for creating osteotomies. There is no mention of AI, ML, image processing, or any data-driven decision-making or analysis capabilities.
No
Explanation: This device is a surgical drill designed to create an osteotomy, which is a preparatory step for implant placement, not for treating a disease or condition itself.
No
Explanation: The device is described as a surgical tool for cutting bone to prepare for dental implant placement. Its function is interventional/surgical, not primarily diagnostic (e.g., detecting, monitoring, or predicting diseases/conditions).
No
The device description clearly states it is a physical drill constructed of surgical grade stainless steel with an amorphous diamond coating, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device's intended use is to "cut into the maxilla or mandible to create an osteotomy for endosseous dental implant placement." This is a surgical tool used directly on the patient's body for a physical procedure.
- Lack of Biological Sample Analysis: There is no mention of the device being used to analyze biological samples or provide diagnostic information based on such analysis.
Therefore, based on the provided information, this device is a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use for this device is to cut into the maxilla or mandible to create an osteotomy for endosseous dental implant placement. The amorphous diamond coated drill design is intended to minimize corrosion and to increase longevity of the tool.
Product codes
DZI
Device Description
The Amorphous Diamond Coated Drill is designed for use in the preparation of an osteotomy for an endosseous dental implant site. The Amorphous Diamond Coated Drill is constructed of surgical grade stainless steel. The bone cutting portion of the drill is coated with amorphous diamond coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxilla or mandible
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)
Biological and mechanical test data were performed to support the indications for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Nobel Biocare USA, Inc. Steri-Oss System Surgical Drill
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.
0
JUN 10 1999
Original 510(k) Amorphous Diamond Coated Drill
Image /page/0/Picture/2 description: The image shows a sequence of handwritten alphanumeric characters. The characters appear to be 'K990896'. The writing style is cursive and somewhat stylized, with some characters connected to each other. The image is in black and white.
Section 6 510(k) Summary
Manufacturer Information:
... . . . -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| Submitter's Name: | Nobel Biocare USA, Inc. |
|---|---|
| Address: | 22895 Eastpark Drive |
| Yorba Linda, CA 92887 | |
| USA | |
| Contact Name: | Kim Rendon |
| Regulatory Affairs Analyst | |
| Phone: | 714-282-4800 |
| Date Prepared: | March 1999 |
Device Name:
| Common Name: | Surgical Drill. |
|---|---|
| Trade Name: | Amorphous Diamond Coated Drill. |
| Classification Name: | Bone cutting instrument and accessories. |
Predicate Device:
Substantial equivalence is claimed to Nobel Biocare USA, Inc. Steri-Oss System Surgical Drill.
Device Description:
Device Function: The Amorphous Diamond Coated Drill is designed for use in the preparation of an osteotomy for an endosseous dental implant site.
Scientific Concepts: Bone cutting instrument.
Page 1 of 2
Nobel Biocare USA March 1999
1
Characteristics: The Amorphous Diamond Coated Drill is constructed of surgical grade stainless steel. The bone cutting portion of the drill is coated with amorphous diamond coating.
Intended Use:
The drill is used to cut into the maxilla or mandible to create an osteotomy for endosseous dental implant placement.
Comparison to Predicate:
| Characteristic | Nobel Biocare
Steri-Oss System
Titanium Nitride Coated
Drills | Amorphous Diamond
Coated Drill |
|----------------|------------------------------------------------------------------------|-----------------------------------|
| Material | Stainless Steel | Same |
| Coating | Titanium Nitride | Amorphous Diamond |
| Design | Latch end to use with
handpiece | Same |
| Cutting Flutes | Two | Three |
| Irrigation | Internal | Internal or external |
| Sterility | Non-sterile | Same |
| Packaging | Plastic vial with foam
inserts | Same |
Performance Data:
Biological and mechanical test data were performed to support the indications for use.
2
Image /page/2/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 an eagle or bird in flight, composed of three stylized, curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 0 1999
Ms. Kim Rendon Regulatory Affairs Analyst Nobel Biocare USA, Incorporated 22895 East Park Drive Yorba Linda, California 92887
Re : K990846 Amorphous Diamond Coated Drill Trade Name: Requlatory Class: II Product Code: DZI Dated: March 12, 1999 Received: March 15, 1999
Dear Ms. Rendon:
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, Druq, 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, labelinq, and prohibitions against 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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Rendon
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.
If you desire specific 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) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "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 its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda/gov/cdrh/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Original 510(k) Amorphous Diamond Coated Drill
Section 8 Indications for Use
Page 1 of 1
510(k) Number (if known):
Device Name: Amorphous Diamond Coated Drill
Indications For Use:
The intended use for this device is to cut into the maxilla or mandible to create an osteotomy for endosseous dental implant placement. The amorphous diamond coated drill design is intended to minimize corrosion and to increase longevity of the tool.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Susan Kunn | |
|---|---|
| (Division Sign-Off) | |
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| 510(k) Number | K990846 |
| Prescription Use _(Per 21 CFR 801.109) | OR Over-The-Counter Use _ |
(Optional Format 1-2-96)
Nobel Biocare USA March 1999