(477 days)
No
The summary describes a physical dental implant and its associated components, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is an endosseous implant intended to restore patient esthetics and chewing function by anchoring or supporting tooth replacements, which pertains to structural restoration rather than treating or curing a disease or medical condition.
No
This device is an implantable medical device (dental implant) used to restore chewing function and esthetics, not to diagnose a condition.
No
The device description clearly states it is a physical implant made of commercially pure titanium, ranging in length and diameter, and includes a cover screw. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the NobelParallel™ Conical Connection implants are "endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting replacements to restore patient esthetics and chewing function." This describes a surgical implant used in vivo (within the body) for structural support and functional restoration.
- 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 outside the body.
- Device Description: The device description details a physical implant made of titanium, designed for surgical placement in bone. This aligns with an in vivo medical device, not an in vitro diagnostic test.
The information provided consistently describes a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
NobelParallel™ Conical Connection implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting replacements to restore patient esthetics and chewing function.
NobelParallel™ Conical Connection implants are indicated for single or multiple restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical techniques in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.
Implants with
§ 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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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 21, 2019
Nobel Biocare AB % Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda. California 92887
Re: K173418
Trade/Device Name: NobelParallel™ Conical Connection Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: January 21, 2019 Received: January 22, 2019
Dear Charlemagne Chua:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Andrew I. Steen -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173418
Device Name NobelParallelTM Conical Connection
Indications for Use (Describe)
NobelParallel™ Conical Connection implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting replacements to restore patient esthetics and chewing function.
NobelParallel™ Conical Connection implants are indicated for single or multiple restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical techniques in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.
Implants with Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(k) Summary
l. Submitter
Submitted by:
Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887
Contact Person: Charlemagne Chua, Head Regulatory Affairs, US/CAN Phone: (714) 282-4800 x7830 Fax: (714) 998-9348
Submitted for:
Nobel Biocare AB Vastra Hamngatan 1 Goteburg, SE-411 17 Sweden
Date Prepared: February 21, 2019
II. Device
| Device Proprietary
| Name: | NobelParallel™ Conical Connection |
|---|---|
| Common or Usual | |
| Name: | Endosseous Dental Implant |
| Classification Name: | Endosseous Dental Implants |
| Regulation Number: | 21 CFR 872.3640 |
| Product Code: | DZE |
| Device Classification | II |
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lll. Predicate Device
| | Device Name | Applicant | 510(k)
Number |
|----------------------|----------------------------------------------------------------------|------------------------------------------------------------------------------------|-------------------------------|
| Primary
Predicate | NobelActive® | NOBEL BIOCARE AB | K142660 |
| Reference
Devices | GROOVY IMPLANTS
LEGACY3 6MM LENGTH IMPLANTS
NobelSpeedy Groovy | NOBEL BIOCARE AB
IMPLANT DIRECT SYBRON
MANUFACTURING LLC
NOBEL BIOCARE AB | K050258
K131097
K160119 |
The following device are referenced in the Substantial Equivalence Discussion
Device Description IV.
NobelParallel™ Conical Connection (herein referred to as NobelParallel™ CC) implants are threaded, root-form, endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore a patient's chewing function.
The sterile, single-use only implants, made of commercially pure titanium (ASTM F67-13), range in length from 6.5 – 17.5 mm (physical implant length) and are provided in four (4) diameters (Ø 3.75 mm, 4.3 mm, 5.0 mm, and 5.5 mm). The implants feature a conical connection which is compatible with Nobel Biocare's narrow platform (NP), regular platform (RP), and wide platform (WP) abutments. The conical connections are color coded to identify the compatible abutment platform(s).
Each implant is individually packaged and provided with its corresponding titanium alloy cover screw (Ti-6Al-4V, per ASTM F136-13 and ISO 5832-3).
V. Indications for Use
NobelParallel™ Conical Connection implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting replacements to restore patient esthetics and chewing function.
NobelParallel™ Conical Connection implants are indicated for single or multiple restorations in splinted or non-splinted applications. This can be achieved by a 2stage or 1-stage surgical techniques in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.
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Implants with