(22 days)
Not Found
No
The summary describes a dental implant system and does not mention any AI or ML components or functionalities.
Yes.
The device is intended to restore chewing function, which is a therapeutic purpose.
No
The device is described as an implant system designed to restore chewing function, not to diagnose a condition or disease.
No
The device description clearly states it is an "implant" made of titanium with an HA coating, indicating it is a physical hardware device.
No, 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. This information is used for diagnosis, monitoring, or screening.
- Device Description: The Replace™ Scalloped Margin Implant System is a physical implant designed to be surgically placed into the jawbone to restore chewing function. It is a surgical implant, not a device that analyzes biological samples.
- Intended Use: The intended use is to "restore chewing function in edentulous and/or partially edentulous patients." This is a functional restoration, not a diagnostic test.
The information provided clearly describes a surgically implanted device, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The Replace™ Scalloped Margin Implant System is an implant with a scalloped coronal margin, designed for single stage or two stage surgical procedures. The Replace™ Scalloped Margin Implant System is intended for use to restore chewing function in edentulous and/or partially edentulous patients.
Product codes
DZE
Device Description
The Replace " Scalloped Margin Implant System is an implant with a scalloped coronal margin designed to mimic the contours of the alveolar ridge. The implant is designed for esthetic applications where the alveolar ridge and the soft tissues are relatively intact.
The available diameters will be 3.5 mm, 4.3 mm, 5.0 mm and 6.0 mm with lengths of 10 mm, 13 mm and 16 mm. The titanium implant body will be available with an HA coating on the root form portion.
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)
Replace™ HA Coated Implant K962845
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.
0
JUN 0 5 2002
Nobel Biocare
Section 1.5
Safety and Effectiveness Summary
| Submitted by: | Richard T. Ross, RAC | |
|---|---|---|
| Senior Regulatory Affairs Specialist | ||
| Address: | Nobel Biocare USA, Inc. | |
| 22715 Savi Ranch Parkway | ||
| Yorba Linda , CA 92887 | ||
| Telephone: | (714) 282-4800, ext. 7830 | |
| (800) 993-8100, ext. 7830 | ||
| Fax: | (714) 998-9348 | |
| Date Submitted: | April 26, 2002 | |
| Classification Name: | Endosseous Dental Implant (21 CFR 872.3640) | |
| Trade or Proprietary or | Replace™ Scalloped Margin Implant System | |
| Model Name: | ||
| Legally Marketed Device: | Replace™ HA Coated Implant | K962845 |
Device Description:
The Replace " Scalloped Margin Implant System is an implant with a scalloped coronal margin designed to mimic the contours of the alveolar ridge. The implant is designed for esthetic applications where the alveolar ridge and the soft tissues are relatively intact.
The available diameters will be 3.5 mm, 4.3 mm, 5.0 mm and 6.0 mm with lengths of 10 mm, 13 mm and 16 mm. The titanium implant body will be available with an HA coating on the root form portion.
Indications for Use:
The Replace™ Scalloped Margin Implant System is an implant with a scalloped coronal margin, designed for single stage or two stage surgical procedures. The Replace™ Scalloped Margin Implant System is intended for use to restore chewing function in edentulous and/or partially edentulous patients.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a caduceus, which is a symbol of medicine. The caduceus is made up of three lines that curve and intersect. The seal is black and white.
JUN 1 2 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Richard T. Ross Senior Regulatory Affairs Specialist Nobel Biocare USA, Incorporated 22715 Savi Ranch Parkway Yorba Linda, California 92887
Re: K021584
Trade/Device Name: Replace Scalloped Margin Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: May 13, 2002 Received: May 14, 2002
Dear Mr. Ross:
This letter corrects our substantially equivalent letter of June 5, 2002 regarding the trade name.
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). 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.
2
Page 2 - Mr. Ross
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/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
3
Section 1.4
Indications for Use Statement
page 1 of 1
510(k) Number (if known): Not yet assigned
Replace™ Scalloped Margin Implant System Device Name:
Indications for Use:
The Replace™ Scalloped Margin Implant System is an implant with a scalloped coronal margin, designed for single stage or two stage surgical procedures. The Replace™ Scalloped Margin Implant System is intended 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)
Prescription Use V (per 21 CFR 801.109) OR
Over-the-Counter Use Optional Format 1-2-96
Susan Runpo
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital De 510(k) Number -