(176 days)
MH-6
Not Found
No
The description focuses on the mechanical function and design of a dental abutment and does not mention any computational or learning-based components.
Yes
The device is used to restore masticatory function, which is a therapeutic purpose.
No
The device is an abutment for dental prosthetics, designed to provide a foundation for restoring masticatory function. It is not used to diagnose or detect medical conditions.
No
The device description clearly indicates it is a physical abutment designed to be used with dental implants, not a software product.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device description: The description clearly states that this device is an abutment used in conjunction with dental implants to restore chewing function. It is a physical component placed within the mouth.
- Intended Use: The intended use is to provide a foundation for a prosthetic appliance to restore masticatory function. This is a mechanical function, not a diagnostic test performed on a specimen.
The device is a dental implant component, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The intended use of Steri-Oss' Bio-Esthetic Indirect Abutment, an abutment retained with a lingual retaining screw, is to provide a stable, secure foundation upon which a prosthetic appliance (the purpose of which is restoration of masticatory function in the edentulous or partially edentulous patient) can be attached, yet remain retrievable.
Product codes
NHA
Device Description
How device functions: The Steri-Oss Lingual Bio-Esthetic Indirect Abutment is designed to be used in conjunction with endosseous implants as part of a system to provide support for prosthetic appliances to restore patient chewing function, and includes utilization of a lingual refaining screw for abutment retention which allows retrievability.
Scientific concepts; Natural dentition is composed of a root (subgingival) and a crown (supragingival). Implant system designs in existence are intended to mimic this structure to aid the patient in restoring natural masticatory function. The implant is designed to serve as the root of the artificial tooth and the abutment/prosthetic is designed to serve as the crown. The abutment must be securely fastened to the implant. A lingual retaining screw may be used for this purpose, while retaining retrievability.
Characteristics: The Bio-Esthetic Indirect Abutment is a conventional abutment designed for use with a lingual screw which, when tightened, retains the abutment in place.
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 applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Friatec's "Frialit-2 MH-6 Abutment"
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
0
Original 510(k) Bio-Esthetic Indirect Abutment
Ka700073
Section 6 510(k) Summary பரா - 3 பத்து
letterhead
510(k) Summary
Manufacturer Information:
| Submitter's Name: | Steri-Oss Inc. |
|---|---|
| Address: | 22895 Eastpark Drive |
| Yorba Linda, CA 92887, U.S.A. | |
| Contact's Name: | Jeff Hausheer, Ph.D. |
| Regulatory Affairs Specialist | |
| Phone: | 714-282-4800, extension 3815 |
| Date Prepared: | January 1997 |
Device Names:
Common Name: Endosseous Dental Implant Abutment and Lingual Retaining Screw
Trade Name: Bio-Esthetic Indirect Abutment
Classification Name: Endosseous implant
Predicate Device:
Substantial equivalence is claimed to Friatec's "Frialit-2 MH-6 Abutment".
Device Description:
How device functions: The Steri-Oss Lingual Bio-Esthetic Indirect Abutment is designed to be used in conjunction with endosseous implants as part of a system to provide support for prosthetic appliances to restore patient chewing function, and includes utilization of a lingual refaining screw for abutment retention which allows retrievability.
Page 1 of 3
Steri-Oss Inc. - January 1997
1
Original 510(k) Bio-Esthetic Indirect Abutment
Section 6 510(k) Summary (continued)
letterhead
510(k) Summary (continued)
Device Description (continued):
Scientific concepts; Natural dentition is composed of a root (subgingival) and a crown (supragingival). Implant system designs in existence are intended to mimic this structure to aid the patient in restoring natural masticatory function. The implant is designed to serve as the root of the artificial tooth and the abutment/prosthetic is designed to serve as the crown. The abutment must be securely fastened to the implant. A lingual retaining screw may be used for this purpose, while retaining retrievability.
Characteristics: The Bio-Esthetic Indirect Abutment is a conventional abutment designed for use with a lingual screw which, when tightened, retains the abutment in place.
Intended Use:
The intended use of Steri-Oss' Bio-Esthetic Indirect Abutment, an abutment retained with a lingual retaining screw, is to provide a stable, secure foundation upon which a prosthetic appliance (the purpose of which is restoration of masticatory function in the edentulous or partially edentulous patient) can be attached, yet remain retrievable.
Comparison to Predicate:
Table 6.1 provides a comparison of the technological characteristic of the Steri-Oss implant to the predicate.
2
Section 6 510(k) Summary (continued)
Table 6.1
Product Comparison - Abutment with Lingual Retaining Screw
| Characteristic | PREDICATE
Friatec's
"Frialit MH-6 Abutment" | NEW DEVICE
Steri-Oss'
Bio-Esthetic Indirect Abutment |
|---------------------------------|---------------------------------------------------|------------------------------------------------------------|
| Abutment and Screw Material | Titanium alloy | Same |
| Retaining Screw Collar Material | Gold alloy | Gold alloy |
| Abutment Design | Cylindrical shape | Oval cylinder shape with and
without angulation |
| Height (mm) | 0.130 in. to 0.256 in. | 0.350 in. to 0.0359 in. |
| Maximum Diameter (mm) | 0.067 in. to 0.110 in. | 0.230 in. to 0.283 in. |
| Abutment Angulation | Straight | Straight and 15° |
| Packaging | Unknown | Chevron pouch in plastic case |
| Sterility | Unknown | Provided Sterile |
Performance Data:
Not applicable.
Page 3 of 3
Steri-Oss Inc. - January 1997
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 1 7 2010
Ms. Phuong Nguyen Son Regulatory Affairs Manager Nobel Biocare USA. LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887
Re: K970073
Trade/Device Name: Bio-Esthetic Indirect Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Bio-Esthetic Indirect Abutment Regulatory Class: II Product Code: NHA Dated: July 28, 2010 Received: July 29, 2010
Dear Ms. Nguyen Son:
This letter corrects our substantially equivalent letter of July 28, 2010.
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 (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
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.
4
Page 2- Ms. Nguyen Son
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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Susan Runoey
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control Office of Device Evaluation Center for Devices and Radiological Health
5
Original 510(k) Bio-Esthetic Indirect Abutment
Section 9
Indications for Use
Page 1 of 1
510(k) Number (if known): _ K970073_
Device Name: Bio-Esthetic Indirect Abutment
Indications For Use:
The intended use of Steri-Oss' Bio-Esthetic Indirect Abutment retained with a lingual retaining screw, is to provide a stable, secure foundation upon which a prosthetic appliance (the purpose of which is restoration of masticatory function in the edentulous and partially edentulous patient) can be attached, yet remain retrievable.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number | K970073 |
|---|---|
| --------------- | --------- |
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR Over-The-Counter Use ____ (Per 21 CFR 801.109) |
|---|---|
| ----------------------------------------------------- | --------------------------------------------------- |
(Optional Format 1-2-96)
Steri-Oss inc. - January 1997