(17 days)
Replace Scalloped Margin Implant System (K021584)
No
The summary describes a dental implant system with material and design modifications, with no mention of AI or ML capabilities.
No.
The device is an implant system intended to restore chewing function, which is a structural and mechanical function, not a therapeutic treatment.
No
The device is an implant system designed to restore chewing function in edentulous and/or partially edentulous patients. It is a treatment device, not one that identifies or diagnoses a condition.
No
The device description explicitly details physical components like implants, abutments, healing caps/cover plugs, and o-rings, and discusses material changes for these components. This indicates a hardware-based medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "restore chewing function in edentulous and/or partially edentulous patients." This describes a therapeutic or restorative purpose, not a diagnostic one.
- Device Description: The device is an implant system designed to be surgically placed in the body. This is characteristic of a medical device used for treatment, not for testing samples outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition based on sample analysis.
- Using reagents or calibrators.
Therefore, the Nobel Perfect Implant System is a medical device, specifically a dental implant system, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The indications for use for the Nobel Perfect Implant System are the unmodified device, Replace Scalloped Margin Implant System. It is a system with a scalloped coronal implant designed for single stage or two stage surgical procedures. The Nobel Perfect Implant System is intended for use to restore chewing function in edentulous and/or partially edentulous patients.
Product codes
DZE, NHA
Device Description
The Nobel Perfect Implant System is a name change of the legally marketed device Replace Scalloped Margin Implant System. The Nobel Perfect Implant System utilizes the same components (i.e. implant, abutment, etc.) as the predicate device, Replace Scalloped Margin Implant System (K021584), yet contains three design modifications.
First, the screw-retained healing cap is now designed as a shorter, cover plug. The design modification was developed in order to attain a better seal and reduce the overall height of the implant by lowering its profile.
Second, a silicone o-ring has been added to the implant system. The o-ring is intended to be placed between the implant and the healing abutment in order to prevent fluids and tissue from seeping between the two parts during the healing process.
Third, changes in materials have been specified. The material used to manufacture the former screw-retained healing cap was acetal (Delrin). The cover plug and the o-ring will be made from a medical grade translucent silicone. The material used for the manufacture of the healing abutment has changed from acetal (Delrin) to polysulfone so that it may be radiation sterilized.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
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K030257
510(k) Summary of Safety and Effectiveness
FEB 1 0 2003
| Submitted by: | Elizabeth J. Mason, Sr. Regulatory Affairs Specialist |
|---|---|
| Address: | Nobel Biocare USA Inc. |
| 22715 Savi Ranch Parkway | |
| Yorba Linda, CA 92887 | |
| Telephone: | (714) 282-4800, ext. 7830 |
| Facsimile: | (714) 998-9348 |
| Date of Submission: | January 22, 2003 |
| Classification Name: | Endosseous Dental Implant (21 CFR 872.3640) |
| Trade or Proprietary | |
| or Model Name: | Nobel Perfect Implant System |
| Legally Marketed Device: | Replace Scalloped Margin Implant System (K021584) |
Device Description:
The Nobel Perfect Implant System is a name change of the legally marketed device Replace Scalloped Margin Implant System. The Nobel Perfect Implant System utilizes the same components (i.e. implant, abutment, etc.) as the predicate device, Replace Scalloped Margin Implant System (K021584), yet contains three design modifications.
First, the screw-retained healing cap is now designed as a shorter, cover plug. The design modification was developed in order to attain a better seal and reduce the overall height of the implant by lowering its profile.
Second, a silicone o-ring has been added to the implant system. The o-ring is intended to be placed between the implant and the healing abutment in order to prevent fluids and tissue from seeping between the two parts during the healing process.
Third, changes in materials have been specified. The material used to manufacture the former screw-relained healing cap was acetal (Delrin). The cover plug and the o-ring will be made from a medical grade translucent silicone. The material used for the manufacture of the healing abutment has changed from acetal (Delrin) to polysulfone so that it may be radiation sterilized.
Indications for Use:
The indications for use for the Nobel Perfect Implant System are the unmodified device, Replace Scalloped Margin Implant System. It is a system with a scalloped coronal implant designed for single stage or two stage surgical procedures. The Nobel Perfect Implant System is intended for use to restore chewing function in edentulous and/or partially edentulous patients.
Nobel Blocare USA, Inc. Special 510(k) Notification Nobel Perfect January 2003
000009
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with outstretched arms, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 14, 2012
Ms. Elizabeth J. Mason Senior Regulatory Affairs Specialist Nobel Biocare USA, Incorporated 22715 Savi Ranch Parkway YORBA LINDA CA 92887
Re: K030257
Trade/Device Name: Nobel Perfect Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: January 22, 2003 Received: January 24, 2003
Dear Ms. Mason:
This letter corrects our substantially equivalent letter of February 10, 2003 regarding the product code and regulatory class.
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. 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.
2
Page 2 - Ms. Mason
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/CDRH0ffices/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 Runner DDS, MA 2012.12.14
Susan Runner DDS, MA 10:49:43 -0. -10:49:43 -05'00'
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Statement of Indications for Use
Page 1 of 1
K030257 510(k) number (if known):
Device Name: Nobel Perfect Implant System
Indications for Use:
The indications for use for the Nobel Perfect Implant System are the unmodified device, Replace Scalloped Margin Implant System. It is a system with a scalloped coronal implant designed for single stage or two stage surgical procedures. The Nobel Perfect Implant implant decigined for use to restore chewing function in edentulous and/or partially edentulous patients.
(Please do not write below this line - Continue on another page if needed.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kein Muke for MSR
Division of Anesthesiolog Infection Control. Den
510(k) Number: K030257
(Optional Format 3-10-98)
Nobel Blocare USA, Inc. Special 510(k) Notification Nobel Perfect January 2003
000008