The Spiraltech Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patients esthetics and chewing function. Spiraltech implants are intended for single or multiple unit restorations on splinted or non-splinted applications. The implants ESi Dynamic and Ultimate are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants [along with Premium and One Piece] can also be used for loading after a conventional healing period.

Solo One Piece 3.0 and 3.3 implants, Ultimate (conical) 3.0 implants, and ESi (conical) 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. Mandibular central and lateral incisors must be splinted if using two or more 3.0 and/or 3.3 implants adjacent to one another.

Device Description

The SpiralTech implant system is a comprehensive product line that includes implants, corresponding abutments, and closure screws. SpiralTech dental implants are grade 5 titanium (Ti 6Al-4V ELI, conforms to ASTM F136) implants that come in 2 different surface treatments - SLA, and RBM.

SpiralTech dental implants come in five product lines with four based on their thread designs. The ESi has sharp, square, and rounded threads. The Ultimate and Dynamic lines also have sharp threads with the Dynamic having a reverse buttress thread design. The Premium line features square and sharper threads in a more conventional design. The implants have diameters ranging from 3.0 mm, and the lengths from 8mm to 15 mm. ESi, Ultimate, and Dynamic are intended to be used for immediate loading. The fifth implant type is the One Piece which comes with an abutment which cannot be used with low mechanical stability cases.

Abutments are available in various types including straight, shoulder, angulated, ball attachments, multiunit, temporary and healing. All abutments come in both hex and conical connections. Temporary abutments come in PEEK and zirconia. Healing abutments come in titanium alloy and zirconia. Abutments come in titanium alloy and as a titanium base with zirconia abutments and multi-units are titanium alloy. No SpiralTech abutments are intended to be modified.

AI/ML Overview

The SpiralTech Dental Implant System's acceptance criteria and studies are focused on demonstrating substantial equivalence to predicate devices, rather than establishing direct clinical performance metrics against a defined standard. Therefore, the device performance is reported in terms of equivalence to established devices and compliance with relevant standards.

Here's an breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This section is derived from the "Non-Clinical Testing" and "Substantial Equivalence" sections, as well as the comparison tables. The acceptance criteria essentially reflect conformance to established standards and similarity to predicate devices.

Acceptance Criterion	Reported Device Performance
Sterilization Validation	Complies with ISO 11737-1, ISO 11737-2, ISO 11137-1, ISO 11137-2, ISO 11137-3 (for gamma radiation), ISO 17665-1, and ISO 17665-2 (for moist heat). Includes USP 85, USP 161, and LAL method testing. Shelf life validated for 5 years based on accelerated testing (ASTM F1980) with one year of real-time data (ASTM F1929-12, ASTM F88/F88M). Predicate/reference devices underwent the same type of sterilization testing.
Fatigue Testing	Designs of SpiralTech Dental Implants were fatigue tested according to ISO 14801. Justification provided to show the tested design was the worst-case for that connection type. Predicate/reference devices underwent the same ISO 14801 testing.
Surface Analysis	Implants with SLA and RBM surface treatments evaluated by SEM and EDS for surface analysis. (Implied acceptance: surfaces are comparable to predicate devices and suitable for dental implants).
Biocompatibility	Cytotoxicity (MEM elution) provided to demonstrate biocompatibility for all subject devices composed of Ti6Al4V, ZrO2, and PEEK. (Implied acceptance: materials are biocompatible and comparable to predicate devices).
Material Composition	Implants: Grade 5 titanium (Ti 6Al-4V ELI, conforms to ASTM F136). Abutments: Ti6Al4V or ZrO2. Temporary Abutments: PEEK. Chemical characterization of ZrO2 provided. Materials used are commonly found in predicate and reference devices.
Dimensions (Diameters)	Implants: 3.0-6.0mm (Hex: 3.3, 3.5, 4.3, 5.0, 6.0; Conical: 3.0, 3.5, 4.3, 5.0, 6.0; Solo: 3.0, 3.3, 3.75, 4.2). The widths are in the same range as predicate and reference devices (e.g., NobelActive: 3.5-5.5mm, Tapered SwissPlus: 3.7, 4.8mm).
Dimensions (Lengths)	Implants: 8-15mm (specific lengths vary by design and diameter). The lengths are in the same range as predicate and reference devices (e.g., NobelActive: 8.5-11.5mm, Biohorizons: 7.5-15mm).
Thread Designs	ESi (sharp, square, rounded threads), Ultimate (sharp threads), Dynamic (sharp threads, reverse buttress), Premium (square, sharper threads). These thread designs incorporate types of threads used in predicate and reference devices (specific references to Biohorizons, NobelReplace and NobelActive for various thread designs).
Connection Types	Hex and conical. These are types used in several predicate devices (e.g., NobelActive: hex, NobelReplace: conical).
Surface Treatments	SLA and RBM. These are the same types as those used on predicate devices (e.g., NobelActive: acid etched, NobelReplace: HA, acid etched, Biohorizons: RBM, MIS: SLA).
Indications for Use	Consistent with the predicate device, with more restrictive placement for smaller diameter implants (Solo One Piece 3.0/3.3, Ultimate conical 3.0, ESi conical 3.0 for lateral incisors in maxilla and/or central/lateral incisors in mandible, with splinting requirement for mandibular central/lateral incisors if two or more 3.0/3.3 implants are adjacent). The general indications are substantially equivalent to Nobel Biocare's NobelActive implants.

2. Sample size used for the test set and the data provenance

The document describes non-clinical laboratory testing, not clinical studies involving patient data. Therefore, there isn't a "test set" in the sense of patient data.

Sample Size for Testing: The specific sample sizes for fatigue testing, sterilization validation, SEM/EDS analysis, and biocompatibility testing are not explicitly stated in the provided text. They are implied to be sufficient for compliance with the referenced ISO and ASTM standards.
Data Provenance: The studies are non-clinical, laboratory-based tests conducted following international standards (ISO, ASTM, USP). There is no country of origin for "data" in the context of patient information, nor is it retrospective or prospective. The data originates from the manufacturer's testing or contracted laboratories.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device's approval is based on substantial equivalence through non-clinical testing and comparison to predicate devices, not on interpretation of patient data by a panel of human experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as there is no "test set" requiring expert adjudication.

5. 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 document pertains to a dental implant system, which is a physical medical device, not an AI-powered diagnostic or decision support system.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable, as this is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context is the established performance and safety requirements outlined in international standards (ISO, ASTM, USP) for dental implants and materials, as well as the documented characteristics of the predicate and reference devices. For example:

Sterility: Demonstrated by meeting specified sterility assurance levels (SAL) according to ISO standards.
Mechanical Strength: Demonstrated by meeting fatigue resistance criteria according to ISO 14801.
Biocompatibility: Demonstrated by passing cytotoxicity tests (MEM elution) and material characterization (SEM, EDS) in accordance with relevant standards.
Design & Materials: Comparison to the known, established designs and materials of legally marketed predicate devices.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable. There is no "training set."

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 30, 2017

SpiralTech Superior Dental Implants Daniel Rosenthal Director of Sales and Marketing 875 N. Michigan Ave Suite 3106 Chicago, Illinois 60611

Re: K170372

Trade/Device Name: SpiralTech Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 29, 2017 Received: June 5, 2017

Dear Daniel Rosenthal:

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.

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

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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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Andrew I. Steen -S

for Lori A. Wiggins, MPT, CLT 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) K170372

Device Name SpiralTech Dental Implant System

Indications for Use (Describe)

The Spiraltech Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patients esthetics and chewing function. Spiraltech implants are intended for single or multiple unit restorations on splinted applications. The implants ESi Dynamic and Ultimate are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants [along with Premium and One Piece] can also be used for loading after a conventional healing period.

Solo One Piece 3.0 and 3.3 implants. Ultimate (conical) 3.0 implants, and ESi (conical) 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. Mandibular central and lateral incisors must be splinted if using two or more 3.0 and/or 3.3 implants adjacent to one another.

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)

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510(k) Summary June 17, 2017

SpiralTech Dental Implants

Company: SpiralTech Superior Dental Implants

Address: 875 N. Michigan Ave Suite 3106 Chicago, IL 60611

Phone: 312-440-7777

Contact Person: Daniel Rosenthal

Contact email: info@spiraltech.com

Trade Name: SpiralTech Dental Implant System

Common Name: dental implant and abutment system

Classification Name: endosseous dental implant

Regulation Number: 21 CFR 872.3640

Product Code: DZE

Secondary Product Code: NHA

Predicate Device: Nobel Biocare K071370

Reference Devices: Implants – Nobel Biocare K133731 K020646 K102436 Biohorizons K121787 Zimmer K082639 MIS K080162 K103089 Abutments - Biohorizons K071638 Alpha Bio Tec K063364 MSI K112162

Indications for Use

Solo One Piece 3.0 and 3.3 implants, Ultimate (conical) 3.0 implants, and ESi (conical) 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central incisor in the mandible. Mandibular central and lateral incisors must be splinted if using two or more 3.0 and/or 3.3 implants adjacent to one another.

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Device Description

Sizes

The Hex versions of the designs are available in 3.3, 3.5, 4.3, 5.0, and 6.0 with lengths 8, 10, 11, 13, and 15. The conical versions start at a diameter of 3.5 but are otherwise available in the same sizes and lengths with one exception, the Ultimate and ESi designs also come in 3.0 diameter with lengths of 10, 11, 13, and 15.

Diameter (mm)	Implant Lengths (mm)
3.3mm	8, 10, 11.5, 13, 15mm
3.5mm	8, 10, 11.5, 13, 15mm
4.3mm	8, 10, 11.5, 13, 15mm
5.0mm	8, 10, 11.5, 13, 15mm
6.0mm	8, 10, 11.5, 13, 15mm

Hex version implant sizes:

Conical version implant sizes:

Diameter (mm)	Implant Lengths (mm)
3.0mm	10, 11.5, 13, 15mm – only for Ultimate and ESi implants
3.5mm	8, 10, 11.5, 13, 15mm
4.3mm	8, 10, 11.5, 13, 15mm
5.0mm	8, 10, 11.5, 13, 15mm
6.0mm	8, 10, 11.5, 13, 15mm

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The Solo one piece implant comes in diameters 3.0, 3.3, 3.75, and 4.2. It has lengths of 10, 11, 13 and 15.

The smallest diameter conical versions for the ESi, Ultimate, Dynamic and Premium implants are only compatible with the 0° and 15° titanium conical abutment models.

The smallest diameter hex versions for the ESi, Ultimate, Dynamic and Premium implants are only compatible with the 0°, 15° and 25° titanium hex abutment models.

Non-Clinical Testing

Sterilization validation was conducted for the implants according to the respective standards, ISO 11737-1, ISO 11737-2, ISO 11137-1, ISO 11137-2, and ISO 11137-3 (for gamma radiation validation) and ISO 17665-1 and ISO 17665-2 (for moist heat validation). This testing included USP 85, USP 161 and LAL method testing on the implants. The shelf life for the implants supplied sterile is 5 years based on accelerated testing (ASTM F1980) with one year of real time data (ASTM F1929-12, ASTM F88/F88M).

Several designs of SpiralTech Dental Implants were fatigue tested according to ISO 14801. Justification was provided to show the design tested was the worst case for that connection type. The implants with SLA and RBM surface treatments were evaluated by SEM and EDS for surface analysis.

The temporary abutments are made of PEEK. The implants are Ti6Al4V with either SLA or RBM surface treatment. Abutments are either Ti6AL4V or ZrO2. Chemical characterization of the ZrQ2 was provided. Cytotoxicity (MEM elution) has been provided to demonstrate biocompatibility for all subject devices composed of these identified materials.

Substantial Equivalence

The widths and lengths of the implants are in the same range as the predicate and reference devices. The materials used for all the devices are commonly used in the predicate and reference devices. As can be seen in the table, the thread designs incorporate types of threads used in the predicate and reference devices. The implant connections types are ones used in several predicate devices as can be seen in the table. The indications for use are the predicate device, except for adding more restrictive placement for the Solo One Piece 3.0 and 3.3 implants, Ultimate (conical) 3.0 implants, and ESi (conical) 3.0 implants. The surface treatments available are the same types as those used on predicate devices.

The testing done for sterilization validation is the same type of testing done on the predicate and reference devices. Also the predicate and reference devices underwent the same ISO 14801 testing.

See the Substantial Equivalence Tables.

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Conclusion

The SpiralTech Dental Implants are substantially equivalent to the predicate device based on design including implant connection, materials, surface treatments, dimensions, and testing completed.

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Substantial Equivalence Table

Implant Table

	SpiralTech	NobelActiveK071370 andK133731	NobelReplaceK020646	NobelActive3.0K102436	InternalTaperedPlus fromBiohorizonsK121787	TaperedSwissPlusfromZimmerK082639	MIS UnoK080162	MISShortimplantsK103089
Material	Ti6Al4V	CP Titanium	Ti6Al4V	CP Titanium	Ti6Al4V	Ti6Al4V	Ti6Al4V	Ti6Al4V
Diameters	3.0 – 6.0with theexact sizesvaryingamong thedesigns.	3.5, 4.3, 5.0,5.5	3.5, 4.3, 5.0,6.0	3.0	3.8, 4.6, 5.8	3.7, 4.8	3.0 and3.5	4.2, 5.0,6.0
Lengths	8, 10, 11, 13,15 with notall lengthsavailable forall sizes anddesigns	8.5, 10, 11.5	10, 13, 16	10, 11.5, 13,15	7.5, 9, 10.5,12, 15	8, 10, 12,14	10, 13, 16	6.0
Indicationsfor Use	TheSpiraltechDentalImplants areendosseousimplantsintended tobe surgicallyplaced in theupper orlower jawarches to	NobelBiocare'sNobelActiveimplants areendosseousimplantsintended tobe surgicallyplaced in thebone of theupper orlower jaw

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providesupport forprostheticdevices,such as anartificialtooth, inorder torestorepatientsestheticsand chewingfunction.Spiraltechimplants areintended forsingle ormultiple unitrestorationson splintedor non-splintedapplications.The implantsESi Dynamicand Ultimateare intendedforimmediateloadingwhen goodprimarystability isachieved	arches toprovidesupport forprostheticdevices, suchas anartificialtooth, inorder torestorepatientesthetics andchewingfunction.NobelBiocare'sNobelactiveimplants areindicated forsingle ormultiple unitrestorationsin splintedand non-splintedapplications.NobelBiocare'sNobelActiveimplants areintended forimmediateloading whengood primary
and with	stability is
appropriate	achieved and
occlusive	with
loading.	appropriate
These	occlusal
implants	loading.
[along with
Premium
and One
Piece] can
also be used
for loading
after a
conventional
healing
period.
Solo One
Piece 3.0
and 3.3
implants,
Ultimate
(conical) 3.0
implants,
and ESi
(conical) 3.0
implants are
intended to
replace a
lateral
incisor in the
maxilla
and/or a
central or
lateral

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ESI threaddesignreferencedevice				X
Dynamicthreaddesignreferencedevice			X
Premiumthreaddesignreferencedevice		X
Ultimatethreaddesignreferenceandpredicate	X

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device
One Piecethreaddesignreferenceandpredicatedevice						X
RadiationSterilizationof theImplants	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes
ValidatedSteamSterilizationInstructionssuppliedforabutments	Yes	Yes	Yes	Yes	Yes	Yes	No abutments	Yes
Subject ofFatiguetestingmeetingISO 14801	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes
Connectioninterface	hex, conical	hex	conical	hex	hex	octagon	N/A	hex
SurfaceTreatmentsAvailable	SLA, RBM	Acid etched	HA, acidetched	TiUnite	RBM	HA, RBM	SLA	SLA

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Abutment Table

Abutments		Hex	ConicalNP	Conical RP
Flat TitaniumStraight	3.8(Narrow)	FacialHeights -5,7,9,11	FacialHeights -5,7,9,11	FacialHeights –5,7,9,11
Flat TitaniumStraight	4.5(Standard)	FacialHeights –5,7,9,11	FacialHeights -5,7,9,11	FacialHeights -5,7,9,11
Flat TitaniumStraight	5.5 (Wide)	FacialHeights -5,7,9,11		FacialHeights -5,7,9,11
Flat TitaniumShoulder	3.8	FacialHeights -1,2,3	FacialHeights -1,2,3,4	FacialHeights -1,2,3
Flat TitaniumShoulder	4.5	FacialHeights -1,2,3	FacialHeights -1,2,3,4	FacialHeights -1,2,3
Flat TitaniumShoulder	5.5	FacialHeights -1,2,3	FacialHeights -1,2,3,4	FacialHeights -1,2,3
AnatomicTitanium	4.5	FacialHeights -1,2,3,4	FacialHeights -1,2,3,4	FacialHeights -1,2,3,4
AnatomicTitanium	5.5	FacialHeights -1,2,3	FacialHeights –1,2,3	FacialHeights -1,2,3
15 DegreeAngulated -	4.7	FacialHeights -	FacialHeights –	FacialHeights -
Titanium
25 DegreeAngulated -Titanium	5.2	FacialHeights -1,2,3	FacialHeights -1,2,3	FacialHeights -1,2,3
30 DegreeAngulated -Titanium	5.3	FacialHeights -1,2,3	FacialHeights -1,2,3	FacialHeights -1,2,3
Flat TitaniumSlim	3.7			FacialHeights -1,2,3
15 degreeAngulatedTitanium slim	3.7			FacialHeights -1,2,3
TitaniumMultiunitAbutments -Straight	-	FacialHeights -1,2,3,4	FacialHeights -1,2,3,4	FacialHeights -1,2,3,4
TitaniumMultiunitAbutments -17 Degreeangulated	-	FacialHeights -1,2,3,4	FacialHeights -1,2,3,4	FacialHeights -1,2,3,4
TitaniumMultiunitAbutments -30 degreeangulated	-	FacialHeights -1,2,3	FacialHeights -1,2,3	FacialHeights -1,2,3
TitaniumHealingAbutment	3.8	FacialHeights -2,3,4,5,6	FacialHeights -2,3,4,5,6	FacialHeights -2,3,4,5,6
TitaniumHealing	4.5	FacialHeights -	FacialHeights -	FacialHeights -
Abutment
TitaniumHealingAbutment	5.5	Facial Heights -2,3,4,5,6	Facial Heights -2,3,4,5,6	Facial Heights -2,3,4,5,6
ZirconiaAnatomicAbutments	4.5	Facial Heights -1,2,3	Facial Heights -1,2,3
ZirconiaHealingAbutment	3.8	Facial Heights -2,3,4,5,6	Facial Heights -2,3,4,5,6	Facial Heights -2,3,4,5,6
ZirconiaHealingAbutment	5.5	Facial Heights -3,4		Facial Heights -3,4
PEEKTemporary FlatAbutments	Length - 10	Facial Heights -1,2,3	Facial Heights -1,2,3	Facial Heights -1,2,3
PEEKTemporary FlatAbutments	Length - 11	Facial Heights -1,2,3	Facial Heights -1,2,3	Facial Heights -1,2,3
PEEKTemporary FlatAbutments	Length - 12	Facial Heights -1,2,3	Facial Heights -1,2,3	Facial Heights -1,2,3
PEEKTemporaryanatomicAbutments	Length - 10	Facial Heights -1,2,3	Facial Heights -1,2,3	Facial Heights -1,2,3
PEEKTemporaryAnatomicAbutments	Length - 11	Facial Heights -1,2,3	Facial Heights -1,2,3	Facial Heights -1,2,3
PEEKTemporaryAnatomicAbutments	Length - 12	Facial Heights -1,2,3	Facial Heights -1,2,3	Facial Heights -1,2,3
Abutments
ImplantProstheticIndicator	-	Facial Heights –1,2,3,4,5,6	Facial Heights –1,2,3,4,5,6	Facial Heights –1,2,3,4,5,6
BallAttachments	-	Facial Heights –1,2,3,4,5,6	Facial Heights –1,2,3,4,5,6	Facial Heights –1,2,3,4,5,6

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	SpiralTech (Internal Hexand ConicalConnection)	Biohorizon (ConicalInternal Hex) K071638	Alpha Biotec (InternalHex Connection)K063364	MIS (Internal Hex)K112162
Straight TitaniumAbutments	Diameters – 3.8,4.5,5.5Facial Heights - 5,7,9,11	Laserlok SimpleabutmentsDiameters - 3.8,4.5,5.5Facial Heights - 5,7,9,11	Titanium AbutmentsDiameters -3.85,4.5,5.3Facial Heights - 6,7,8,9	Straight TitaniumAbutmentsDiameters - 3.8,4.5,5.5Facial Heights - 5,7,9,11
Anatomic Titaniumabutments	Diameter - 4.5Facial Heights - 1,2,3,4Diameter - 5.5Facial Heights - 1,2,3	Straight EstheticconnectionsDiameters –3.0,3.5,4.5,5.7Facial Heights - 1,2,3	Anatomic Abutmentswith Emergence ProfileDiameter - 4.3Facial Heights - 1.5,2Diameter - 5.5Facial Heights - 2,3
Shoulder Titaniumabutments	Diameter - 3.8Facial Heights - 1,2,3Diameter - 4.5Facial Heights - 1,2,3,4Diameter - 5.5Facial Heights - 1,2,3		Straight abutments withvarious cuff heightsDiameter - 3.85Facial Heights -0.5,1.5,2.5Diameter - 4.8Facial Heights - 1,2,3,4Diameter - 5.6Facial Heights - 2,4
Angulated titaniumabutments	15 Degree - Diameter -4.7 - Heights - 1,2,325 Degree - Diameter -5.2 - Heights - 1,2,330 Degree - Diameter -5.3 - Heights - 2,3,4,5	15 Degree - Diameter -4.5,5.7 - Heights - 2,325 Degree - Diameter -5.2 - Heights - 1,2,330 Degree - Diameter -5.3 - Heights - 2,3,4,5	Angled Abutments15 Degree - Diameter -4.5,4.8,5.1 - Heights -1,2,325 Degree - Diameter -4.7, 5.3 - Heights - 1,2,3
			35 Degree - Diameter -4.65, 5.3 - Heights -1,2,3
Titanium Healingabutments	Diameter - 3.8Facial Heights -2,3,4,5,6Diameter - 4.5Facial Heights -2,3,4,5,6Diameter - 5.5Facial Heights -2,3,4,5,6	Titanium HealingabutmentsDiameter - 3.8Facial Heights - 1,3,5Diameter - 4.7Facial Heights - 1,3,5Diameter - 5.7Facial Heights - 1,3,5	Titanium HealingabutmentsDiameter - 3.8Facial Heights - 3,4,5Diameter - 4.5Facial Heights -2,3,4,5,6,7Diameter - 5,5.5,6,7,7.8Facial Heights - 3,5	Titanium HealingabutmentsDiameter - 3.8Facial Heights -2,3,4,5,6,7Diameter - 5.5Facial Heights - 3,4,5,6
Zirconia Abutments -Anatomic	Diameter - 4.5Facial Heights - 1,2,3			Straight AnatomicZirconiaDiameter - 4.5Facial Heights - 1,2,3,4
Zirconia Healingabutments
Multi unit abutments	StraightDiameter - 4.7Facial Heights - 1,2,3,417 DegreeDiameter - 5.3Facial Heights -1,2,330 DegreeDiameter - 5.4Facial Heights - 1,2,3	Multi unit abutmentsStraightDiameter - 4.5Facial Heights -1,2,3,4,517 DegreeDiameter - 4.5Facial Heights -2.25,3,430 DegreeDiameter - 3.5,4.5	StraightDiameter - 4.7Facial Heights -1.5,2.5,3,4,517 DegreeDiameter - 5.3Facial Heights -2,330 DegreeDiameter - 5.4Facial Heights - 2,3	StraightDiameter - 4.7Facial Heights -1,2,3,4,5,617 DegreeDiameter - 5.3Facial Heights -2,330 DegreeDiameter - 5.4Facial Heights - 2,3
		Facial Heights - 3,4,5
PEEK temporaryabutments Straight	Diameter - 4.5Facial Heights - 1,2,3	Temporary PEEKabutmentsDiameter -3.0,3.5,4.5,5.7Facial Heights - 3
PEEK temporaryabutments Anatomic	Diameter - 4.5Facial Heights - 1,2,3		Temporary PEEKabutmentsDiameter - 5.4Facial Heights - 1,2,3
Ball attachments	Heights - 1,2,3,4,5,6	Ball attachmentsDiameter - 4.5Facial Heights - 1,3,5	Titanium BallattachmentsHeights - 0.5,2,3,4,5,6	Titanium BallattachmentsHeights - 1,2,3,4,5,6

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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.