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 <7mm length are for delayed loading only when appropriate stability has been achieved.

Device Description

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).

AI/ML Overview

The provided text is a 510(k) Summary for a medical device called NobelParallel™ Conical Connection implants. It describes the device, its intended use, comparison to predicate devices, and performance data provided for substantial equivalence determination.

Here's a breakdown of the requested information based on the provided text. Please note that the document is a summary and therefore may not contain all the granular details of a full study report.

Acceptance Criteria and Device Performance

This document does not explicitly state acceptance criteria in a quantitative table format with corresponding device performance values. Instead, it describes differences and similarities to predicate devices and lists the types of studies performed to support substantial equivalence. The implication is that the device's performance, as demonstrated by these studies, met the FDA's criteria for substantial equivalence to existing legally marketed devices.

However, based on the performance data listed, we can infer the types of performance evaluated:

Performance Aspect	Implied Acceptance Criteria (relative to predicates)	Reported Device Performance (as implied by the summary)
Clinical Performance (Short Implants <7mm)	Safe and effective for its intended use, particularly for short implants, demonstrating comparable outcomes to similar devices.	Retrospective multi-center single cohort clinical study on NobelParallel Conical Connection short implant (<7mm) was conducted. Outcome details are not provided in this summary.
Fatigue Strength	Meets or exceeds the fatigue strength of predicate devices.	Comparative fatigue testing in accordance with ISO 14801 was conducted. Specific results or comparative values are not provided in this summary.
Surface Area (Short Implants <7mm)	Comparable surface area characteristics to relevant devices.	Comparative surface area analysis for short implants (<7 mm) was conducted. Specific results are not provided in this summary.
Sterilization	Achieves sterility assurance level (SAL) as required for medical devices.	Sterilization validation in accordance with ISO 11137-1:2006 + Amd 1:2013 and EN ISO 11137-2:2013 was conducted. Specific results are not provided in this summary.
Packaging and Transport	Maintains device integrity and sterility during transport and storage.	Packaging and transport validation in accordance with ISO 11607-1:2009 + Amd 1:2014 was conducted. Specific results are not provided in this summary.
Shelf-life	Maintains device integrity and sterility over its stated shelf-life.	Shelf-life studies in accordance with ASTM F1980-2016 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices were conducted. Specific results are not provided in this summary.
Endotoxin Content	Meets regulatory limits for endotoxin.	Endotoxin testing in accordance with USP <161 Medical Devices-Bacterial Endotoxin and Pyrogen Tests and ANSI/AAMI ST72:2011/ (R)2016 was conducted. Specific results are not provided in this summary.

Detailed Study Information (Based on available text):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Clinical Study: "retrospective multi-center single cohort clinical study on NobelParallel Conical Connection short implant (<7mm)."
  - Sample Size: Not specified in the summary.
  - Provenance: "multi-center" implies multiple locations, but specific countries are not mentioned. "retrospective" indicates data was collected on events that occurred in the past.
- Non-clinical tests: For fatigue, surface area, sterilization, packaging, shelf-life, and endotoxin, sample sizes are not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- The document describes a clinical study and non-clinical tests for a dental implant. Establishing "ground truth" in the typical sense (like for AI image analysis) doesn't directly apply here. The clinical study would involve patient outcomes assessed by clinicians. For non-clinical tests, "ground truth" is typically established by recognized standards (e.g., ISO, ASTM, USP) and laboratory protocols, not by expert consensus in the same way an AI model's output would be adjudicated. No specific number or qualifications of experts for establishing "ground truth" are mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable in the context of this 510(k) summary for a dental implant's performance assessment. Adjudication methods like 2+1 are typically for establishing ground truth for diagnostic AI algorithms, not for evaluating physical device performance or clinical outcomes in general.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a 510(k) summary for a physical medical device (dental implant), not a diagnostic AI device requiring MRMC studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable, as this is not an algorithm or AI device.
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Clinical Study: The clinical study would rely on "outcomes data" related to the performance of the short implants. This could include implant survival rates, bone integration, complications, etc., as assessed by treating clinicians.
- Non-clinical tests: The "ground truth" for non-clinical tests is based on established regulatory standards (ISO, ASTM, USP) and laboratory measurements of physical and material properties.
The sample size for the training set
- Not applicable. This is a 510(k) summary for a physical medical device, not an AI/ML algorithm that requires a training set.
How the ground truth for the training set was established
- Not applicable, as there is no training set for a physical medical device.

Summary

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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)

Implants with <7mm length are for delayed loading only when appropriate stability has been achieved.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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K173418

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 ProprietaryName:	NobelParallel™ Conical Connection
Common or UsualName:	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
PrimaryPredicate	NobelActive®	NOBEL BIOCARE AB	K142660
ReferenceDevices	GROOVY IMPLANTSLEGACY3 6MM LENGTH IMPLANTSNobelSpeedy Groovy	NOBEL BIOCARE ABIMPLANT DIRECT SYBRONMANUFACTURING LLCNOBEL BIOCARE AB	K050258 K131097 K160119

The following device are referenced in the Substantial Equivalence Discussion

Device Description IV.

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 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 <7mm length are for delayed loading only when appropriate stability has been achieved.

Comparison of Technological Characteristics VI.

The NobelParallel™ CC implants are similar to the predicate devices as follows:

same implant/abutment connection type as the NobelActive Implant . (K142260), and
same implant body design, including slightly tapered walls and tapered apex . with cutting flutes, as the NOBELSPEEDY™ Groovy Implants (K160119).

The NobelParallel™ CC implants are technologically different from the predicate devices as follows:

. the longest length of the subject device NobelParallel™ CC is within the range of predicate device NOBELSPEEDY™ Groovy,
. the smallest implant diameter of the subject device NobelParallel™ CC is within the range of the predicate device NobelSpeedy™ Groovy implants, and
the use of new drill protocols is required.

Comparisons of the subject and predicate implants and cover screws are provided in the following tables.

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Comparison of Indications for Use Statements

ATTRIBUTE	Subject Device	Primary Predicate	Reference Device		Reference device
		Nobel Biocare	Nobel Biocare	Nobel Biocare	Implant Direct
	NobelParallel™Conical Connection	NobelActive®(K142260)	NobelSpeedy®Groovy (K160119)	NobelReplace MK IIIGroovy (K050258)	Legacy3 6mm(K131097)
Indications forUse	NobelParallel™Conical Connectionimplants areendosseous implantsintended to besurgically placed in theupper or lower jawbone for anchoring orsupporting toothreplacements torestore patientesthetics and chewingfunction.	NobelActive® implantsare endosseousimplants intended to besurgically placed in theupper or lower jawbone for anchoring orsupporting toothreplacements torestore patientesthetics and chewingfunction.NobelActive® implantsare indicated for singleor multiple unitrestorations in splintedor non-splintedapplications. This canbe achieved by a 2-stage or 1-stagesurgical technique incombination withimmediate, early ordelayed loadingprotocols, recognizingsufficient primary	NobelSpeedy® Groovyimplants areendosseous implantsintended to besurgically placed in theupper or lower jawbone for anchoring orsupporting toothreplacements torestore patientesthetics and chewingfunction.NobelSpeedy® Groovyimplants are indicatedfor single or multipleunit restorations insplinted or non-splintedapplications. This canbe achieved by a 2-stage or 1-stagesurgical technique incombination withimmediate, early ordelayed loadingprotocols recognizing	Nobel Biocare'sGroovy Implants areroot-form endosseousimplants intended to besurgically placed in thebone of the upper orlower jaw arches toprovide support forprosthetic devices,such as an artificialtooth, in order torestore patientesthetics and chewingfunction.Nobel Biocare'sGroovy Implants areindicated for single ormultiple unitrestorations in splintedor non-splintedapplications.Nobel Biocare GroovyImplants may beplaced immediately	The Legacy DentalImplant is a dentalimplant fixture that is apart of a two-pieceimplant system. Thelegacy implants areintended for use in themandible and maxilla,in support of single ormultiple-unit cement orscrew receiving fixedrestorations and forretention and supportof overdentures. Theimplants are intendedfor immediateplacement and functionfor support of singletooth and/or multipletooth restorations,recognizing bonestability andappropriate occlusalload requirements.

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delayed loadingprotocols, recognizingsufficient primarystability andappropriate occlusalloading for the selectedtechnique.Implants with < 7mmlength are for delayedloading only whenappropriate stabilityhas been achieved.	stability andappropriate occlusalloading for the selectedtechnique.NobelActive® 3.0implants are intendedto replace a lateralincisor in the maxillaand/or a central orlateral incisor in themandible.NobelActive® 3.0implants are indicatedfor single unitrestorations only.	sufficient primarystability andappropriate occlusalloading for the selectedtechnique. Implantsallow also for bicorticalanchorage in cases ofreduced bone density.NobelSpeedy® Groovyimplants 20, 22, 25 mmwhen placed in themaxilla are onlyindicated for multipleunit restorations insplinted applicationsthat utilize at least twoimplants.	and put into immediatefunction providing thatthe initial stabilityrequirements detailedin the surgical manualsare satisfied.Groovy implants areindicated for use in softbone in posteriorregions wheneverimmediate or earlyloading is applied. TheGroovy implantsincorporate a grooveon the implant threadand are preferred overmodels without thegroove in these softbone indicationsbecause bone formsmore rapidly in thegroove than on otherparts of the implantresulting in increasedstability whencompared to non-grooved implants
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Comparison of Key Technological Characteristics

ATTRIBUTE	Subject Device	PrimaryPredicateNobel Biocare -1	Reference device- 2Nobel Biocare	Reference device- 3Nobel Biocare	Reference device- 4Implant Direct	Comments
	NobelParallel™ConicalConnection	NobelActive®(K142260)	NobelSpeedy®Groovy (K160119)incl. K050406	NobelReplace MKIII Groovy(K050258)	Legacy3 6mmLength Implants(K131097)
ThreadDesign	Double leadthread with groove	Double leadthreadReverse cuttingflutes	Single lead threadwith groove	Double leadthread withgrooves	Double leadthreaded	Double threadsame as 1Groove same as 2Groove Same as 2
ConnectionType	Internal Conical*	Internal Hex	External Hex	Internal Tri-channel	Leading bevel, ahex and a 1-72UNF thread	Same as 1
Implant BodyDesign	Tapered apex withbone cutting flutes,slightly taperedbody	Expanding TaperDrilling blades onapex	Tapered apex withbone cutting flutes,slightly taperedbody	Straight bodydesign based onthe Branemark MkIII Groovy. Slightlytapered apex butnot like Speedy	Tapered body	Same as 2
Cutting Flutes	4 apical flutes	2 conical helix-shaped flutes, 1/3turns (120°)	4 apical flutes	3 apical flutes	Unknown+	Same as 2
Implant lengthand diameter(physicaldimensions)	$Ø$ 3.75mm: 6.5,8.0, 9.5, 11.0,12.5, 14.5, 17.5mm	$Ø$ 3.5mm: 8.0, 9.5,11.0, 12.5, 14.5,17.5 mm	Speedy replace: $Ø$3.5mm: 10.25,11.75, 13.25,15.25,	$Ø$ 3.5mm: 9.25,10.75, 12.25,14.25 mm	$Ø$ 3.7mm: 6mm;	Length:• Min length:6.5 mm longerthan 4• other lengthssame as 1
						Diameter:• Larger than1,2,3• Slightlysmaller than 4
Ø 4.3mm: 6.5,8.0, 9.5, 11.0,12.5, 14.5, 17.5mm	Ø 4.3mm: 8.0,9.5, 11.0, 12.5,14.5, 17.5 mm	Ø 4.0mm: 7.25,8.75, 10.25, 11.75,13.25, 15.25,18.25, 20.25,22.25, 25.25 mm	Ø 4.0mm: 9.25,10.75, 12.25,14.25, 17.25 mm	Ø 4.2mm: 6mm;		Length:• Min length:6.5 mm longerthan 4• other lengthssame as 1Diameter:• Larger/Sameas 1, 2, 3, 4
Ø 5.0mm: 6.5,8.0, 9.5, 11.0,12.5, 14.5, 17.5mm	Ø 5.0mm: 8.0,9.5, 11.0, 12.5,14.5, 17.5 mm	Ø 5.0mm: 7.25,8.75, 10.25, 11.75,13.25, 15.25,18.25 mm		Ø 4.7mm: 6mm;Ø 5.2mm: 6mm;		Length:• Min length:longer than 4• other lengthssame as 1Diameter:• Larger/Sameas 1, 2, 4
Ø 5.5mm: 6.5,8.0, 9.5, 11.0,12.5, 14.5 mm	Ø 5.5mm: 6.5,8.0, 9.5, 11.0, 12.5mm	Ø 6.0mm: 7.25,8.75, 10.25, 11.75,13.25, 15.25,18.25 mm	Ø 5.0mm: 9.25,10.75, 12.25,14.25, 17.25 mm	Ø 5.7mm: 6mm;Ø 7.0mm: 6mm;		Length:• Max lengthsmaller than2,3• Other lengthssame as 1Diameter:
						• Larger/Sameas 1, 3
ImplantDiameter	3.75, 4.3, 5.0, 5.5mm	3.5, 4.3, 5.0, 5.5mm	3.5, 4.0, 5.0, 6.0mm	3.5, 4.0, 5.0 mm	3.7, 4.2, 4.7, 5.2,5.7, 7.0 mm	Different – seediscussion
ConnectorColor	Magenta - Ø 3.75mm NPYellow - Ø 4.3mm RPYellow - Ø 5.0mm RPBlue - Ø 5.5 mmWP	Magenta - Ø 3.5mm NPYellow - Ø 4.3mm RPYellow - Ø 5.0mm RPBlue - Ø 5.5 mmWP	N/A	Magenta - Ø 3.5mm NPYellow - Ø 4.0mm RPBlue - Ø 5.0 mmWP	Unknown+	Same
CompatibleAbutments	Internal conicalconnection:NP Ø 3.0 mmRP Ø 3.4 mmWP Ø 4.4 mm	Internal conicalconnection:NP Ø 3.0 mmRP Ø 3.4 mmWP Ø 4.4 mm	External hexconnectionNP, RP, WP	Internal Tri-channel: NP, RP,WP	Unknown+	Same as 1
	K071370: EstheticAbutment ConicalConnection,Narrow ProfileAbutment ConicalConnectionK072129:Procera® EstheticAbutment ConicalConnectionK083100:GoldAdapt™ Non-Engaging ConicalConnection	K071370: EstheticAbutment ConicalConnection,Narrow ProfileAbutment ConicalConnectionK072129:Procera® EstheticAbutment ConicalConnectionK083100:GoldAdapt™ Non-Engaging ConicalConnection			Unknown+	Same as 1

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NobelParallel™ Conical Connection (CC) Traditional 510(k)

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NobelParallel™ Conical Connection (CC) Traditional 510(k)

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Previously named Internal Hex

+Unknown based on 510(k) summary

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Comparison of Cover Screws

ATTRIBUTE	Subject device	Primary Predicate	Comments
	NobelParallel™ CC	NobelActive® (K142260)
Design	Image: NobelParallel CC design	Image: NobelActive design
Material	Ti6Al4V	Ti6Al4V	Same
Surface	Anodization	Machined surface / Anodization	Same

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Discussion

As seen above, the NobelParallel™ CC implant has the same internal conical connection (previously named Internal Hex) as the NobelActive Implants (K142260). Both the subject and the predicate devices are made of pure titanium and share the same TiUnite surface. Furthermore, the NobelParallel™ CC implant body follows the same design principles as the NOBELSPEEDY™ Groovy Implants (K160119), including the slightly tapered body and tapered apex with cutting flutes. The difference between the NobelParallel™ CC implants and the predicates is the availability of slightly larger outer diameters in the implants with diameters below 5.0 mm. The diameters are within the existing range of cleared implant diameters NobelActive implant (K142260) and Legacy3 6mm (K131097). Therefore, this difference does not raise questions substantial equivalence.

NobelParallel™ CC implant indications for use differ to the predicate device NobelActive Implants (K142260) in:

Inclusion of a specific for short implants (< 7 mm) statement on limitations of loading protocols, which is not applicable to the predicate device as it is not available in length < 7 mm. The reference device Legacy3 6mm (K131097) indications for use include a similar statement on recognizing bone stability and appropriate occlusal load requirements.
. Exclusion of language regarding 3.0 diameter implants as the subject device is not available in 3.0 diameter.

The subject cover screws are made of the same material as the predicate and have slightly different geometry. Their surface is color coded, using an anodization technique, to identify the compatible implants.

VII. Performance Data

The following safety and performance data were provided in support of the substantial equivalence determination:

a. Clinical:
- retrospective multi-center single cohort clinical study on NobelParallel . Conical Connection short implant (<7mm).
b. Non-clinical:
- comparative fatigue testing in accordance with ISO 14801; .
- comparative surface area analysis for short implants (<7 mm); .
- sterilization validation in accordance with ISO 11137-1:2006 + Amd 1:2013 . and EN ISO 11137-2:2013;
- packaging and transport validation in accordance with ISO 11607-1:2009 + ● Amd 1:2014;

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shelf-life studies in accordance with: .
- ASTM F1980-2016 Standard Guide for Accelerated Aging of Sterile O Barrier Systems for Medical Devices
endotoxin testing in accordance with: ●
- o USP <161 Medical Devices-Bacterial Endotoxin and Pyrogen Tests
- o ANSI/AAMI ST72:2011/ (R)2016 Bacterial endotoxins Test methods, routine monitoring, and alternatives to batch testing

VIII. Conclusion

The technological differences between the subject and predicate devices do not raise new questions of safety and effectiveness. As seen above, the NobelParallel™ CC is the same or similar to the predicate devices in terms of intended use, materials of construction, design, size, surface treatment, and sterilization. The data within this submission support that the NobelParallel™ CC is substantially equivalent to the identified predicate/references devices.

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Regulation Number and Section

§ 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.