(85 days)
No
The device description and performance studies focus on the physical properties and testing of dental abutments, with no mention of AI or ML.
No
The device is described as a prosthetic component for dental rehabilitation, not as a device used to treat or cure a disease or condition.
No
The device description clearly states "NobelPerfect Abutments are pre-manufactured prosthetic components... intended for use as an aid in prosthetic rehabilitation", indicating a treatment or restorative function, not a diagnostic one.
No
The device description explicitly states the device consists of physical components ("healing and definitive abutments") made of a specific material ("titanium vanadium alloy") and includes physical testing (fatigue limit using ISO 14801).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "pre-manufactured prosthetic component directly connected to the endosseous dental implant and are intended for use as an aid in prosthetic rehabilitation." This describes a device used in vivo (within the body) for structural support and restoration, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a physical component made of titanium vanadium alloy that connects to a dental implant. This aligns with a medical device used for treatment or restoration, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any reagents, assays, or procedures for analyzing biological samples (like blood, urine, tissue, etc.), which are hallmarks of IVD devices.
Therefore, the NobelPerfect Abutments are classified as a medical device used in dental procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NobelPerfect Abutments are pre-manufactured prosthetic components directly connected to the endosseous dental implant and are intended for use as an aid in prosthetic rehabilitation.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The NobelPerfect Abutments are direct replacement abutments for the Replace Scalloped Margin Implant System which was marketed under the trade name NobelPerfect. The NobelPerfect Abutments consist of both healing and definitive abutments. Both abutment types are co-packed with the necessary clinical screw. The NobelPerfect Abutments are available for the narrow platform (NP), regular platform (RP), and wide platform (WP). The definitive abutments are 12.0 mm height from the base of the abutment and have no angulation. Both the healing and definitive abutments are made of titanium vanadium alloy.
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)
Summary of Non-Clinical Testing:
Since the subject device does not represent a new worst case, data from the reference predicate device TREFOIL System (K170135) was leveraged in the following aspects of the 510(k).
- Sterile Device Information
- The sterilization method for the subject device is the same as the predicate. The sterilization method is Gamma radiation and has been validated in accordance with ANSI/AAMI/ISO 11137. Therefore, no additional testing was required.
- Device Packaging
- The packaging for the subject device is the same as the predicate. This is a thermoform tray with peel top lid. Therefore, no additional testing was required.
- Shelf Life
- The packaging for the subject device is the same as the predicate and is labeled with a 3 year expiration date. Real time aging was used to determine the expiration dating. Therefore, no additional testing was required.
- Biocompatibility
- The subject device is manufactured from the same material as the predicate, uses the same manufacturing method as the predicate, has the same intended use, and the same patient contact type and duration. Therefore, no additional testing was required.
The fatigue limit of the NobelPerfect Abutment was determined using ISO 14801.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 14, 2017
Nobel Biocare AB Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda. California 92887
Re: K172854
Trade/Device Name: NobelPerfect Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: September 19, 2107 Received: September 20, 2017
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. 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.
1
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); 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.
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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.
Mary S. Runner -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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| Form Approved: OMB No. 0910-0120 |
|---|
| Expiration Date: January 31, 2017 |
| See PRA Statement below. |
| 510(k) Number (if known) | K172854 |
|---|---|
| Device Name | NobelPerfect Abutments |
| Indications for Use (Describe) | The NobelPerfect Abutments are pre-manufactured prosthetic components directly connected to the endosseous dental implant and are intended for use as an aid in prosthetic rehabilitation. |
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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."
| FORM FDA 3881 (1/14) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 | EF |
|---|---|---|---|
| ---------------------- | ------------- | ---------------------------------------- | ---- |
da ുട്ടുകൂട്ടു വിട്ടുകളുടെ പ്രശസ്തുക
3
I. SUBMITTER
Nobel Biocare AB Vastra Hamngatan 1 Goteborg, SE-411 17 Sweden
Submitted by: Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887
Contact Person: Charlemagne Chua, Senior Regulatory Affairs Manager Phone: (714) 282-4800 x 7830 Fax: (714) 998-9348
Date Prepared: December 13, 2017
II. DEVICE
Name of Device: NobelPerfect Abutments Common or Usual Name: Endosseous Dental Implant Abutment Classification Name: Endosseous Dental Implant (21 CFR 872.3630) Regulatory Class: II Product Code: NHA
III.PREDICATE DEVICE
Primary Predicate Replace Scalloped Margin Implant System (K021584)
Reference Predicate: TREFOIL System (K170135) NobelActive Wide Platform (K133731)
IV. DEVICE DESCRIPTION
The NobelPerfect Abutments are direct replacement abutments for the Replace Scalloped Margin Implant System which was marketed under the trade name NobelPerfect. The NobelPerfect Abutments consist of both healing and definitive abutments. Both abutment types are co-packed with the necessary clinical screw.
A.4.
4
The NobelPerfect Abutments are available for the narrow platform (NP), regular platform (RP), and wide platform (WP). The definitive abutments are 12.0 mm height from the base of the abutment and have no angulation. Both the healing and definitive abutments are made of titanium vanadium alloy.
V. INDICATIONS FOR USE
The NobelPerfect Abutments are pre-manufactured prosthetic components directly connected to the endosseous dental implant and are intended for use as an aid in prosthetic rehabilitation.
Comparison of Predicate and NobelPerfect Abutments Indications for Use
| Technological
| characteristics | Subject Device | Predicate (primary) |
|---|---|---|
| NobelPerfect Abutments | Replace Scalloped Margin Implant | |
| System (K021584) | ||
| Indication for | ||
| Use1 | The NobelPerfect Abutments are pre- | |
| manufactured prosthetic components | ||
| directly connected to the endosseous | ||
| dental implant and are intended for use | ||
| as an aid in prosthetic rehabilitation. | 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 - Note: K021584 does not include a separate indications for use statement for the abutments included in the Replace Scalloped Marqin Implant System. Therefore, an abutment specific indications for use statement was created for the subject devices which falls within the intended use of the primary predicate and the indications for restoring chewing function. "
VI. Comparison of Technological Characteristics
Comparison of Predicate and NobelPerfect Abutment Technological Characteristics
| Technological
| characteristics | Subject Device | Predicate (primary) | |
|---|---|---|---|
| NobelPerfect Abutments | Replace Scalloped Margin Implant | ||
| System (K021584) | |||
| Design Features | Compatible | ||
| Implant | |||
| Platform | Replace Scalloped Margin Implants | ||
| (renamed NobelPerfect Implants) |
- Narrow Platform (NP)
- Regular Platform (RP)
- Wide Platform (WP) | Replace Scalloped Margin Implants
(renamed NobelPerfect Implants) - Narrow Platform (NP)
- Regular Platform (RP)
- Wide Platform (WP) |
| | Device
Material | Titanium vanadium alloy (ASTM F1472,
ASTM F136) | Titanium vanadium alloy (ASTM F1472,
ASTM F136) |
| | Abutment
design | Single piece design with scalloped sides
and base extension. | Single piece design with scalloped sides |
5
| Technological
| characteristics | Subject Device | Predicate (primary) | |
|---|---|---|---|
| NobelPerfect Abutments | Replace Scalloped Margin Implant | ||
| System (K021584) | |||
| Abutment | |||
| height | 12.0 mm from base | 7.5 mm from base | |
| Abutment | |||
| width | NP – 3.39 x 3.035 mm | ||
| RP – 3.75 x 3.09 mm | |||
| WP – 4.255 x 3.50 mm | NP – 3.32 x 3.035 mm | ||
| RP – 3.75 x 3.09 mm | |||
| WP – 4.255 x 3.5 mm | |||
| Abutment | |||
| Angulation | No angulation | No angulation |
Comparison of Predicate and NobelPerfect Healing Abutment Technological Characteristics
| Technological
| characteristics | Subject Device | Predicate (primary) | |
|---|---|---|---|
| NobelPerfect Abutments | Replace Scalloped Margin Implant | ||
| System (K021584) | |||
| Design Features | Compatible | ||
| Implant | |||
| Platform | Replace Scalloped Margin Implants | ||
| (renamed NobelPerfect Implants) |
- Narrow Platform (NP)
- Regular Platform (RP)
- Wide Platform (WP) | Replace Scalloped Margin Implants
(renamed NobelPerfect Implants) - Narrow Platform (NP)
- Regular Platform (RP)
- Wide Platform (WP) |
| | Device
Material | Titanium vanadium alloy (ASTM F1472,
ASTM F136) | Delrin - White |
| | Abutment
design | Single piece design with scalloped
implant interface and base extension | Single piece design with scalloped
implant interface |
| | Abutment
height | NP – 3.86 mm from base
RP – 4.51 mm from base
WP – 4.28 mm from base | 4.95 mm from base |
| | Abutment
diameter
(major) | NP – 4.305 mm
RP – 5.065 mm
WP – 5.775 mm | NP – 4.3 mm
RP – 5.08 mm
WP – 5.775 mm |
| | Scallop
taper | NP - 0°
RP - 4.8°
WP - 5.2° | 0° |
Analysis of Differences Between Subject Device and Predicate
The NobelPerfect Abutments are replacement abutments for the existing NobelPerfect implant system. Both the definitive and healing abutments have been redesigned to include some improvements. The definitive abutments differ from the predicate abutments in that they have a base extension that extends into the implant that is intended to improve abutments stability. The abutments are also longer than the predicate to facilitate more restorative options. The healing abutments are made of titanium alloy instead of Delrin plastic as the predicate is. The RP and WP platform healing abutments have a slight scallop taper whereas the predicate is straight.
6
Summary:
The design differences between the subject and predicate were evaluated. Differences in technology were evaluated through performance testing.
VII. PERFORMANCE DATA
Summary of Non-Clinical Testing:
Since the subject device does not represent a new worst case, data from the reference predicate device TREFOIL System (K170135) was leveraged in the following aspects of the 510(k).
- -Sterile Device Information
- o The sterilization method for the subject device is the same as the predicate. The sterilization method is Gamma radiation and has been validated in accordance with ANSI/AAMI/ISO 11137. Therefore, no additional testing was required.
- -Device Packaging
- o The packaging for the subject device is the same as the predicate. This is a thermoform tray with peel top lid. Therefore, no additional testing was required.
- -Shelf Life
- The packaging for the subject device is the same as the predicate and o is labeled with a 3 year expiration date. Real time aging was used to determine the expiration dating. Therefore, no additional testing was required.
- -Biocompatibility
- The subject device is manufactured from the same material as the o predicate, uses the same manufacturing method as the predicate, has the same intended use, and the same patient contact type and duration. Therefore, no additional testing was required.
The fatigue limit of the NobelPerfect Abutment was determined using ISO 14801.
VIII. CONCLUSIONS
The NobelPerfect Abutments were evaluated for substantial equivalence using standard testing. In cases where the NobelPerfect Abutments could be shown to not represent a worst-case with respect to the predicates, data from these predicate devices was leveraged to support the subject device. Based on technological characteristics and non-clinical test data included in this submission, the NobelPerfect Abutments have been shown to be substantially equivalent to the Replace Scalloped Margin Implant System (K021584).