(92 days)
IPS e.max® Press Abutment Solutions for Nobel Biocare is intended for use in partially or fully endentuous mandibles and maxillae in support of single or multiple-unit cement retained restorations.
IPS e.max Press Abutment Solutions for Nobel Biocare is recommended for the fabrication of:
- Hybrid abutments for single-tooth restorations -
- -Hybrid abutment crowns for restorations
IPS e.max Press will be used to press full ceramic pressed hybrid abutment crowns, or a customized hybrid abutment part which are luted on to recommended titanium connector abutments.
The provided document describes the IPS e.max® Press Abutment Solutions for Nobel Biocare (K124008), a dental device. The study demonstrating its acceptance is primarily a mechanical fatigue test under dynamic loading.
Here's the information as requested:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from ISO 14801:2007) | Reported Device Performance |
|---|---|
| Dynamic fatigue performance | Demonstrated substantial equivalence to the predicate device in dynamic fatigue performance. |
Note: The specific quantitative acceptance criteria of ISO 14801:2007 (e.g., number of cycles at a certain load without failure) are not explicitly stated in the provided text, only that the device "meets" them and is "substantially equivalent" to the predicate. The performance is reported as meeting the ISO standard and achieving substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated. The text mentions "Fatigue tests... were completed using Nobel Biocare Replace Select Tapered TiU NP implant, Ø=3,5 mm, I=11.5mm and Snappy abutment 4.0 NobelReplace NP 0.75." This indicates at least one setup was tested, but the total number of samples or repetitions is not specified.
- Data Provenance: Not specified. It's likely an in-house laboratory study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not applicable. This study is a mechanical performance test, not a clinical study requiring human experts for ground truth. The "ground truth" is established by adherence to the ISO 14801:2007 standard.
4. Adjudication Method for the Test Set:
- Not applicable. This was a mechanical test, not a subjective assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No. The document explicitly states: "Clinical Studies: Clinical testing is not required and has not been performed." Therefore, an MRMC study was not conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- Not applicable. This is a physical dental device, not a software algorithm. The "standalone performance" is its mechanical performance in a laboratory setting, which was indeed evaluated.
7. The Type of Ground Truth Used:
- Standardized Mechanical Performance Metrics: The ground truth for this device is based on the performance requirements outlined in the ISO 14801:2007 standard for "Dynamic fatigue performance applicable to endosseous implant systems."
8. The Sample Size for the Training Set:
- Not applicable. As this is a mechanical device, there is no "training set" in the context of an algorithm or AI.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As there is no training set for this device.
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510(K) SUMMARY
MAR 2 9 2013
IPS e.max Press Abutment Solutions for Nobel Biocare K124008
| Contact: | Donna Marie Hartnett |
|---|---|
| Company: | Ivoclar Vivadent, Inc. 175 Pineview Drive, Amherst, NY 14228(716) 691-0010 |
| Date Prepared: | March 7, 2013 |
| Proprietary Name: | IPS e.max Press Abutment Solutions for Nobel Biocare |
| Classification Name: | Abutment, Implant, Dental, Endosseous |
| Classification Code/Reg: | NHA / 872.3630 |
| Predicate Devices: | IPS e.max Press Abutment Solutions K120053) |
Device Description: IPS e.max Press will be used to press full ceramic pressed hybrid abutment crowns, or a customized hybrid abutment part which are luted on to recommended titanium connector abutments.
The predicate device to which IPS e.max Press Abutment Solutions for Nobel Biocare has been compared is IPS e.max Press Abutment Solutions (K120053). The materials are identical as to chemical composition, performance data and indications for use, except that the predicate device was cleared for use with certain identified Straumann dental implant systems. The subject device has been tested to provide evidence of its expanded compatibility with Nobel Biocare dental implant systems as stated in the Intended Use section below.
The comparison shows that the subject device is substantially equivalent to the predicate device.
Intended Use:
IPS e.max® Press Abutment Solutions for Nobel Biocare is intended for use in partially or fully endentuous mandibles and maxillae in support of single or multiple-unit cement retained restorations.
IPS e.max Press Abutment Solutions for Nobel Biocare is recommended for the fabrication of:
- Hybrid abutments for single-tooth restorations -
- । Hybrid abutment crowns for restorations
The following Ti bases and implant bodies are intended to be used with IPS e.max Press Abutment Solutions for Nobel Biocare.
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510(K) SUMMARY
IPS e.max Press Abutment Solutions for Nobel Biocare K124008
| Implantmanufacturer | Implant system, diameter | Compatible Ti base(abutment), dimensionsgingiva height = GHheight = HTi |
|---|---|---|
| Nobel Biocare | NobelReplace Tapered NP Ø 3.5mm,Length 8, 10, 11.5, 13, 16 mm | Snappy Abutment 4.0internal tri-channelNP, RP, WP, 6.0HTI 4.0 - 5.5mmGH 0.5 - 1.5mm(K062749) |
| Nobel Biocare | NobelReplace Tapered RP Ø 4.3mm,Length 8, 10, 11.5, 13, 16 mm | |
| Nobel Biocare | NobelReplace Tapered WP Ø 5.0mm,Length 8, 10, 11.5, 13, 16 mm | |
| Nobel Biocare | NobelReplace Tapered 6.0 Ø 6.0mm,Length 8, 10, 11.5, 13, 16 mm | |
| Nobel Biocare | Replace Select Tapered NP Ø 3.5mm,Length 8, 10, 11.5, 13, 16 mm | (K050705) |
| Nobel Biocare | Replace Select Tapered RP Ø 4.3mm,Length 8, 10, 11.5, 13, 16 mm | |
| Nobel Biocare | Replace Select Tapered WP Ø 5.0mm,Length 8, 10, 11.5, 13, 16 mm | |
| Nobel Biocare | Replace Select Tapered 6.0 Ø 6.0mm,Length 8, 10, 11.5, 13 mm | |
| Nobel Biocare |
Technological Characteristics: The device design, i.e. delivery form, and intended use of IPS e.max Press Abutment Solutions for Nobel Biocare and the predicate device are the same. The composition of the subject device is identical to the predicate.
Description of the performance aspects Material Composition: Lithium disilicate glass ceramic
Mechanical Properties: Fatigue tests under dynamic loading according to ISO 14801:2007 were completed using Nobel Biocare Replace Select Tapered TiU NP implant, Ø=3,5 mm, I=11.5mm and Snappy abutment 4.0 NobelReplace NP 0.75
IPS e.max Press can be applied as abutment on which a crown is luted (two part solution) or as abutment crown (one part solution).
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510(K) SUMMARY
IPS e.max Press Abutment Solutions for Nobel Biocare K124008
Implant to Abutment Compatibility: Not applicable. The interface between implant and abutment is confirmed by the titanium sleeve. By applying the heat/press technique IPS e.max Press can be processed individually on every indicated titanium sleeve.
Not applicable – components do not consist of dissimilar metals. Corrosion Testing:
Modified Surfaces: Not applicable.
Clinical Studies: Clinical testing is not required and has not been performed.
Testing Summary: The device was tested in accordance with ISO14801:2007 for Dynamic fatigue performance applicable to endosseous implant systems and the results from testing demonstrate that IPS e.max Press Abutment Solutions for Nobel Biocare is substantially equivalent to the predicate device.
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The following Ti bases are intended to be used with IPS e.max Press Abutment Solutions for Nobel Biocare.
| Implantmanufacturer | Implant system, diameter | ConnectionPlatform | Compatible Ti base(abutment)dimensionsgingiva height = GHheight = HTi |
|---|---|---|---|
| Nobel Biocare | NobelReplace Tapered NP Ø 3.5mm, Length 8, 10, 11.5, 13, 16 mmNobelReplace Tapered RP Ø 4.3mm, Length 8, 10, 11.5, 13, 16 mmNobelReplace Tapered WP Ø 5.0mm, Length 8, 10, 11.5, 13, 16 mmNobelReplace Tapered 6.0 Ø 6.0mm, Length 8, 10, 11.5, 13, 16 mmReplace Select Tapered NP Ø 3.5mm, Length 8, 10, 11.5, 13, 16 mmReplace Select Tapered RP Ø 4.3mm, Length 8, 10, 11.5, 13, 16 mmReplace Select Tapered WP Ø 5.0mm, Length 8, 10, 11.5, 13, 16 mmReplace Select Tapered 6.0 Ø 6.0mm, Length 8, 10, 11.5, 13 mm(K050705) | Tri-Channel | Snappy Abutment 4.0 internal tri-channel NP, RP, WP, 6.0HTI 4.0 - 5.5mmGH 0.5 - 1.5mm(K062749) |
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 29, 2013
Ms. Donna Marie Hartnett Director Quality Assurance / Regulatory Affairs Ivoclar Vivadent, Incorporated 175 Pineview Drive AMHERST NY 14228
Re: K124008
Trade/Device Name: IPS e.max® Press - Abutment Solutions for Nobel Biocare Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: December 26, 2012 Received: December 31, 2012
Dear Ms. Hartnett:
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.
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Page 2 - Ms. Hartnett
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 devicerelated 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.
Kwame O.
Sincerely yours,
for
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
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Indications for Use
510(k) Number (if known): : K124008
Device Name: IPS e.max® Press - Abutment Solutions for Nobel Biocare
Indications For Use:
IPS e.max® Press Abutment Solutions for Nobel Biocare is intended for use in partially or fully endentuous mandibles and maxillae in support of single or multiple-unit cement retained restorations.
IPS e.max Press Abutment Solutions for Nobel Biocare is recommended for the fabrication of:
- Hybrid abutments for single-tooth restorations -
- -Hybrid abutment crowns for restorations
Con't next page
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sheena A. Green -S 2013.03.27 11:06:35 -04'00'
for M. Susan Runner, DDS, MA
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 2
510(k) Number:
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The following Ti bases are intended to be used with IPS e.max Press Abutment Solutions for Nobel Biocare. .
| Implantmanufacturer | Implant system, diameter | ConnectionPlatform | Compatible Ti base(abutment)dimensionsgingiva height = GHheight = HTi |
|---|---|---|---|
| Nobel Biocare | NobelReplace Tapered NP Ø 3.5mm,Length 8, 10, 11.5, 13, 16 mmNobelReplace Tapered RP Ø 4.3mm,Length 8, 10, 11.5, 13, 16 mmNobelReplace Tapered WP Ø5.0mm, Length 8, 10, 11.5, 13, 16mmNobelReplace Tapered 6.0 Ø 6.0mm,Length 8, 10, 11.5, 13, 16 mmReplace Select Tapered NP Ø3.5mm, Length 8, 10, 11.5, 13, 16mmReplace Select Tapered RP Ø4.3mm, Length 8, 10, 11.5, 13, 16mmReplace Select Tapered WP Ø5.0mm, Length 8, 10, 11.5, 13, 16mm | Tri-Channel | Snappy Abutment 4.0internal tri-channelNP, RP, WP, 6.0HTI 4.0 - 5.5mmGH 0.5 - 1.5mm(K062749) |
| Replace Select Tapered 6.0 Ø6.0mm, Length 8, 10, 11.5, 13 mm(K050705) |
Page 2 of 2
§ 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.)