K Number

Device Name

ORA 0.4MM [S], ORA 1.0MM [S], ORA 2.0MM [S], ORA 3.0MM [S], ORA 4.0MM [S]

Manufacturer

STERNGOLD DENTAL LLC

Date Cleared

2014-04-16

(124 days)

Product Code

NHA

Regulation Number

872.3630

Intended Use

The ORA Implant Abutment System is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially edentulous patients to restore chewing function. The abutment screws directly into endosseous implants or they screw into SFI Abutments which are screwed into endosseous implants.

Device Description

The ORA Implant Abutment is a precision machined ball shaped abutment that connects a compatible dental implant system with a removable partial or complete overdenture. The implant abutment is screwed into the dental implant. Connection to and retention of a denture is provided by a rubber o-ring, which may or may not be held within a metal housing. There are two color o-rings, a red processing o-ring and a white final o-ring. The retaining ring (metal housing) comes with the red o-ring (which is a firm rubber) inside. The retaining ring (metal housing) with the red o-ring is pushed over the wide part of the ball until seated. The stiffness of the red o-ring holds the housing in position. Any exposed areas of the abutment are blocked out so that only the metal housing is exposed. The retaining ring (metal housing) is then processed into the denture. After the material has cured, the denture is removed. The red o-ring is pulled out of the metal housing and the white o-ring is inserted into its place. The white o-ring is more flexible making insertion and removal easier. The bottom portion of the abutment (cuff area to end of threads) is an exact replica of the SFI Implant Abutments previously cleared by K130183 and K132814. ORA Implant Abutments are available in sixteen different platforms and each platform is compatible with one or more implant types.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K900099, K130183, K132814

Reference Devices

K130183, K132814

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on mechanical components and their function, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are based on non-clinical testing and functional evaluation, not algorithmic performance metrics.

Therapeutic

Yes
The device is indicated for use with dental implants to support and/or retain removable dental prostheses to restore chewing function in partially edentulous patients, which is a therapeutic purpose.

Diagnostic

Explanation: The device is an implant abutment system used to support and/or retain removable dental prostheses. Its function is restorative to support chewing function, not to diagnose a condition.

SaMD (Software as a Medical Device)

The device description clearly details a physical, precision-machined abutment made of metal, along with rubber o-rings and a metal housing. It describes the physical connection to dental implants and dentures, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to support and/or retain removable dental prostheses in the treatment of partially edentulous patients to restore chewing function. This is a direct therapeutic and restorative function within the body.
Device Description: The device is a physical implant abutment that connects to a dental implant and retains a denture. It's a mechanical component used in a surgical and prosthetic procedure.
Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic purposes. IVDs are typically used for testing blood, urine, tissue, etc., to diagnose diseases or conditions.

The device is clearly a medical device used for treatment and restoration within the oral cavity, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

NHA

Device Description

The retaining ring (metal housing) comes with the red o-ring (which is a firm rubber) inside. The retaining ring (metal housing) with the red o-ring is pushed over the wide part of the ball until seated. The stiffness of the red o-ring holds the housing in position. Any exposed areas of the abutment are blocked out so that only the metal housing is exposed. The retaining ring (metal housing) is then processed into the denture. After the material has cured, the denture is removed. The red o-ring is pulled out of the metal housing and the white o-ring is inserted into its place. The white o-ring is more flexible making insertion and removal easier. The bottom portion of the abutment (cuff area to end of threads) is an exact replica of the SFI Implant Abutments previously cleared by K130183 and K132814.

ORA Implant Abutments are available in sixteen different platforms and each platform is compatible with one or more implant types. Table 1 demonstrates implant/abutment compatibility. The difference between each platform is the internal connection with the specific implant. This connection has been previously cleared by K130183 and K132814— SFI Implant Abutments.

The devices are supplied non-sterile, and there is no shelf life.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Oral Cavity

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)

Application and functional testing have been conducted to evaluate the performance characteristics of the ORA Implant Abutments. The test methods used were the same as in predicate devices. Testing has shown that the ORA Implant Abutments included in this application are equivalent in performance characteristics to its predicate devices.

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.

K900099, K130183, K132814

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.

Not Found

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

Regulation Number and Section

§ 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.)

Summary

April 14, 2014 ORA Implant Abutment System

510(k) Summary

APR 1 6 2014

| Sponsor: | Sterngold Dental, LLC
23 Frank Mossberg Drive
Attleboro, MA 02703 |

----------	-------------------------------------------------------------------------

Contact: Maria Rao, QA/RA Director Ph: 508-226-5660 ext 1206
Trade Name: ORA Implant Abutments System
Common Name: Implant Abutments

Classification Name: Endosseous Dental Implant Abutment

Classification: According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II
Product Code: NHA (21CFR 872.3630)

Legally Marketed Device to which Equivalence is claimed (Predicate Devices): Predicate Device(s): K900099, K130183, K132814.

K900099	The O-Ring System - ORS
K130183	SFI Bar® Implant Abutments for 7 Platforms
K132814	SFI Bar® Implant Abutments for 9 Platforms

Description of Device:

The devices are supplied non-sterile, and there is no shelf life.

Intended Use of the Device:

Implant Brand	Model
Nobel Biocare Brånemark System	3.3 Fixture, 3.75 Fixture, 4.0 Fixture, 5.0 Fixture (Old Version), 3.75 MkII Self-tapping Fixture, 4.0
MkII Self-tapping Fixture
Sterngold-ImpiaMed	3.3 Hex Cylinder, 4.0 Hex Cylinder, 3.75 Standard Hex Screw, 3.75 Self-tapping Hex Screw, 3.75
Self-tapping "SST" Hex Screw, 4.0 Standard Hex Screw, 4.0 Self-tapping Hex Screw, 4.0 Self-tapping "SST" Hex Screw, 4.0 Self-tapping "SST" Hex Screw, 5.0 RP "SST" Hex Screw, 3.75 RP
Acid Etched, 4.0 RP Acid Etched, 5.0 RP Acid Etched, 4.1 Stern IC (4.8 head), 3.3 Stern IC (4.8 head)
Nobel Biocare (Steri-Oss®)	3.8 HL Cylinder, 3.8 HL Threaded, 4.5 HL Threaded, 3.5 NobelReplace™, Replace® Select (NP),
4.0 NobelReplace Straight, (RP), 4.3Replace®Select&NobelReplace™ (RP)
Keystone (Lifecore)	3.75 Restore® Self-tapping Screw, 4.0 Restore® Self-tapping Screw, 3.75 Restore® External Hex
Screw, 4.0 Restore® External Hex Screw, 4.0 Restore® External Hex Cylinder, 4.2 Sustain®
External Hex Cylinder, 3.75 Sustain® External Hex Screw, 4.0 Sustain® External Hex Screw, 4.2
Sustain® External Hex MC Cylinder, Stage-1TM (3.3 and 4.0 fixtures)
3i Implant Inovations	3.25 External Hex Miniplant®, 3.25 ICE™ Miniplant®, 3.25 OSSEOTITE® Miniplant®, 3.3 Cylinder
Miniplant®, 3.3 External Hex Cylinder, 3.75 ICE™ Self-tapping, 3.75 OSSEOTITE®, 3.75 Self-tapping Threaded, 3.75 Standard Threaded, 4.0 External Hex Cylinder, 4.0 ICE™ Self-tapping, 4.0
OSSEOTITE®, 4.0 Standard Threaded, 4.25 External Hex Cylinder, TG OSSEOTITE® (4.8
Platform), 4.0 OSSEOTITE® Certain™, 4.0 OSSEOTITE® NTCertain™, 4.0
OSSEOTITE®CERTAIN PREVAIL, 5.0 Osseotite® Certain, 5.0 Osseotite® NT Certain, 5.0
Osseotite®Certain Prevail
IMTEC Corporation®	3.3 Universal Flare Cylinder, 3.75 Universal Self-tapping, 3.75 Universal Self-tapping Coated, 4.0
Spike Cylinder, 4.0 Universal Cylinder
Interpore IMZ™	3.3 Hex Cylinder, 3.75 Self-tapping Threaded, 4.0 Hex Cylinder, 4.0 Self-tapping Threaded, 4.25 Hex
Cylinder
Osstem	4.1 US II, III, II Plus, III Plus, SS II, III (4.8 head)
Zimmer Dental	3.5 Bio-Vent® X™, 3.75 Swede-Vent™ Conical Neck CST, 3.75 Swede-Vent™ Standard, 4.0
Swede-Vent™ Standard, 4.0 Bio-Vent® X™, 3.25 Micro-Vent® (3.5 head), 3.3 Screw-Vent® (3.5
head), 3.5 Bio-Vent® (3.5 head), 3.7 Screw-Vent® (3.5 head), 3.75 Screw-Vent® (3.5 head), 4.3
Core-Vent® (3.5 head), 4.25 Micro-Vent® (4.5 head), 4.5 Bio-Vent® (4.5 head), 4.7 Screw-Vent® (4.5
head), 5.3 Core-Vent® (4.5 head), 3.7 Tapered Swiss Plus™ (4.8 platform), 4.8 Tapered Swiss
Plus™ 4.1 Straight Swiss Plus™, 4.8 Straight Swiss Plus™
Zimmer (Calcitek®, Centerpulse)	3.75 ThreadLoc™
Straumann	ITI TE™ 3.3 (4.8 head), ITI 3.3 Std & Std Plus (4.8 head), ITI TE™ 4.1 (4.8 head), ITI 4.1 Std. & Std.
Plus (4.8 head), ITI, 4.8 Std. & Std. Plus (4.8 head)
Biolok International	4.5 Silhouette Screw, 4.0 Micro-Lok Screw, 4.0 Micro-Lok Cylinder, 3.75 Micro-Lok Screw, 3.3
Micro-Lok Cylinder
Bud	3.25 Bud Screwvent, 3.75 Bud Screwvent
INNOVA	4.1 ENDOPORE® External Connection, 4.0 ENTEGRATM External Connection
OIC	3.0 Osteo Standard ST, 3.25 Osteo Standard ST, 3.75 Osteo Standard ST
MIS IMPLANTS	3.3mm Internal Hex, 3.75mm Internal Hex, 4.20mm Internal Hex, 5.0mm Internal Hex
BioHorizons®	3.5 Internal, 4.0 Internal, 4.5 Internal, 3.5 Single Stage, 4.5 Single Stage
Implant Direct	Legacy 3.5mm, Legacy 4.5mm, RePlant™ 4.3mm, RePlant™ 3.5mm, 3.7mm ScrewPlant, 4.7mm
ScrewPlant
Minimatic/Stryker	3.3 External Hex Cylinder, 3.75 External Hex Screw, 4.0 External Hex Cylinder, 4.0 External Hex
Screw, 4.75 External Hex Screw, 5.0 External Hex Cylinder
Straumann	Straumann Bone Level RC, Blue Sky Bio Square Taper RC
Straumann	Straumann Bone Level NC, Blue Sky Bio Square Taper NC
Ankylos	Ankylos
Nobel Biocare	Nobel Replace WP, Nobel Replace Select WP, NobelSpeedy Replace WP, Implant Direct 5.0
RePlant, BlueSky Bio 5.0 Trilobe
Nobel Biocare	Nobel Conical Connection RP
Nobel Biocare	Nobel Conical Connection NP, Blue Sky Bio Max
Astra Dental	Astra 4.5 / 5.0, Blue Sky Bio Conus 12 4.5 / 5.0
Astra Dental	Astra 3.5 / 4.0, Blue Sky Bio Conus 12 3.5 / 4.0

2 of 4

Technical Characteristics:

The proposed implant abutments are substantially equivalent to the currently marketed predicate devices. The intended use, basic design, fundamental operating principles and manufacturing procedures are the same as the predicate devices.

Attribute	Candidate	Predicate Device	Predicate Device
	The ORA Implant Abutment
Sterngold Dental, LLC	The O-Ring System - ORS
Attachments International,
Inc.
K900099	SFI Implant Abutments
Sterngold Dental, LLC
K130183, K132814
Design/Construction	Machined, screw-retained	Machined, screw-retained	Machined, screw-retained
Anatomical Site	Oral Cavity	Oral Cavity	Oral Cavity
Device Material	Wrought Titanium-6AL-4
Vanadium ELI Alloy	Wrought Titanium-6AL-4
Vanadium ELI Alloy	Wrought Titanium-6AL-4
Vanadium ELI Alloy
Indications for Use	Indicated for use with dental
implants to support and/or retain
removable dental prostheses in
the treatment of partially or
totally edentulous patients to
restore chewing function. The
abutment screws directly into
endosseous implants.	The ORS Implant Abutments are
intended for use with dental
implants as a support or
attachment for prosthetic
restoration. The abutment screws
directly into the implant.	The SFI-Bar® Implant
Abutments are indicated for
use with dental implant
bodies/fixtures to support and
/or retain removable dental
prostheses for partially or
totally edentulous patients to
restore chewing function.
Operating Principle/
Basic Design	Abutment Implant connection:
Screw fixation	Abutment Implant connection:
Screw fixation	Abutment Implant connection:
Screw fixation
	Connecting principle to
overdenture: Retentive system	Connecting principle to
overdenture: Retentive system	Connecting principle to
overdenture: Retentive system
	Cleaning procedures for patient:
Common procedure for oral
hygiene	Cleaning procedures for patient:
Common procedure for oral
hygiene	Cleaning procedures for
patient: Common procedure
for oral hygiene
	Patient handling: Common
cleaning and insertion of denture	Patient handling: Common
cleaning and insertion of denture	Patient handling: Common
cleaning and insertion of
denture
Packaging,
materials and
processes	Produced in a controlled CNC
machine process, previously
validated
Packaging: Pouch
Non-sterile	Produced in a controlled CNC
machine process, previously
validated
Packaging: Pouch
Non-sterile	Produced in a controlled CNC
machine process, previously
validated
Packaging: Pouch
Non-sterile
Cuff Sizes	0.4, 1.0, 1.25, 2.0, 3.0, 4.0,
5.0mm	1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0mm	1.0, 1.5,1.75, 2.0, 2.2, 2.5, 3.0,
3.5, 4.0, 4.5, 5.0, 5.5mm
Prosthetic
Connection	RP, Conical, NP, WP, 3.5 Head,
4.0 Head, 4.1 Head, 4.5 Head,
4.8 Head	RP, Conical, NP, WP, 3.5 Head,
4.0 Head, 4.1 Head, 4.5 Head,
4.8 Head	RP, Conical, NP, WP, 3.5
Head, 4.0 Head, 4.1 Head, 4.5
Head, 4.8 Head

Performance Date:

Safety and Effectiveness / Conclusion:

Non-clinical test data was used to support the substantially equivalence claim. Clinical testing was not necessary. The non-clinical testing consisted of tolerance analysis of platforms to identify worst case test samples. Fatigue testing was not done as the basic design is the same as the predicate devices. The summary of technological characteristics as well as application and functional testing indicate that the device is substantially equivalent to the declared predicate devices.

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 eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

April 16, 2014

Sterngold Dental, LLC Ms. Maria Rao Director, Quality and Regulatory Affairs 23 Frank Mossberg Drive Attleboro, MA 02703

Re: K133791

Trade/Device Name: ORA Implant Abutments System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: March 17, 2014 · Received: March 19, 2014

Dear Ms. Rao:

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 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

Page 2 - Ms. Rao

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor YowIndustry/default.htm. 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/ReportalProblem/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.

Sincerely yours,

Image /page/5/Picture/7 description: The image shows the word "Erin" followed by a logo that is difficult to decipher. The logo appears to be a combination of letters and symbols, possibly representing a company or organization. The text and logo are in black and white, and the overall image has a simple, clean design. The last part of the image shows the letters "h-S".

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Sterngold Dental, LLC Abbreviated 510(k) Premarket Notification

April 14, 2014 ORA Implant Abutment System

510(k) Number (if known):	K133791
---------------------------	---------

Device Name: ORA Implant Abutment System

Indications for Use:

Implant Brand	Model
Nobel Biocare Brånemark System	3.3 Fixture, 3.75 Fixture, 4.0 Fixture, 5.0 Fixture (Old Version), 3.75 MkII Self-tapping Fixture, 4.0 MkII Self-tapping Fixture
Sterngold-ImplaMed	3.3 Hex Cylinder, 4.0 Hex Cylinder, 3.75 Standard Hex Screw, 3.75 Self-tapping Hex Screw, 3.75 Self-tapping "SST" Hex Screw, 4.0 Standard Hex Screw, 4.0 Self-tapping Hex Screw, 4.0 Self-tapping "SST" Hex Screw, 4.0 Self-tapping "SST" Hex Screw, 5.0 RP "SST" Hex Screw, 3.75 RP Acid Etched, 4.0 RP Acid Etched, 5.0 RP Acid Etched, 4.1 Stern IC (4.8 head), 3.3 Stern IC (4.8 head)
Nobel Biocare (Steri-Oss®)	3.8 HL Cylinder, 3.8 HL Threaded, 4.5 HL Threaded, 3.5 NobelReplace™, Replace® Select (NP), 4.0 NobelReplace Straight, (RP), 4.3Replace®Select&NobelReplace™ (RP)
Keystone (Lifecore)	3.75 Restore® Self-tapping Screw, 4.0 Restore® Self-tapping Screw, 3.75 Restore® External Hex Screw, 4.0 Restore® External Hex Screw, 4.0 Restore® External Hex Cylinder, 4.2 Sustain® External Hex Cylinder, 3.75 Sustain® External Hex Screw, 4.0 Sustain® External Hex Screw. 4.2 Sustain® External Hex MC Cylinder. Stage-1TM (3.3 and 4.0 fixtures)
3i Implant Inovations	3.25 External Hex Miniplant®, 3.25 ICE™ Miniplant®, 3.25 OSSEOTITE® Miniplant®, 3.3 Cylinder Miniplant®, 3.3 External Hex Cylinder, 3.75 ICE™ Self-tapping, 3.75 OSSEOTITE®, 3.75 Self-tapping Threaded, 3.75 Standard Threaded, 4.0 External Hex Cylinder, 4.0 ICE™ Self-tapping, 4.0 OSSEOTITE®, 4.0 Standard Threaded, 4.25 External Hex Cylinder, TG OSSEOTITE® (4.8 Platform), 4.0 OSSEOTITE® Certain™, 4.0 OSSEOTITE® NTCertain™, 4.0 OSSEOTITE®CERTAIN PREVAIL, 5.0 Osseotite® Certain, 5.0 Osseotite® NT Certain, 5.0 Osseotite®Certain Prevail
IMTEC Corporation®	3.3 Universal Flare Cylinder, 3.75 Universal Self-tapping, 3.75 Universal Self-tapping Coated, 4.0 Spike Cylinder, 4.0 Universal Cylinder
Interpore IMZ™	3.3 Hex Cylinder, 3.75 Self-tapping Threaded, 4.0 Hex Cylinder, 4.0 Self-tapping Threaded, 4.25 Hex Cylinder
Osstem	4.1 US II, III, II Plus, III Plus, SS II, III (4.8 head)
Zimmer Dental	3.5 Bio-Vent® X™, 3.75 Swede-Vent™ Conical Neck CST, 3.75 Swede-Vent™ Standard, 4.0 Swede-Vent™ Standard, 4.0 Bio-Vent® X™, 3.25 Micro-Vent® (3.5 head), 3.3 Screw-Vent® (3.5 head), 3.5 Bio-Vent® (3.5 head), 3.7 Screw-Vent® (3.5 head), 3.75 Screw-Vent® (3.5 head), 4.3 Core-Vent® (3.5 head), 4.25 Micro-Vent® (4.5 head), 4.5 Bio-Vent® (4.5 head), 4.7 Screw-Vent® (4.5 head), 5.3 Core-Vent® (4.5 head), 3.7 Tapered Swiss Plus™ (4.8 platform), 4.8 Tapered Swiss Plus™ 4.1 Straight Swiss Plus™, 4.8 Straight Swiss Plus™
Zimmer (Calcitek®, Centerpulse)	3.75 ThreadLoc™
Straumann	ITI TE™ 3.3 (4.8 head), ITI 3.3 Std & Std Plus (4.8 head), ITI TE™ 4.1 (4.8 head), ITI 4.1 Std. & Std. Plus (4.8 head), ITI, 4.8 Std. & Std. Plus (4.8 head)
Biolok International	4.5 Silhouette Screw, 4.0 Micro-Lok Screw, 4.0 Micro-Lok Cylinder, 3.75 Micro-Lok Screw, 3.3 Micro-Lok Cylinder
Bud	3.25 Bud Screwvent, 3.75 Bud Screwvent
INNOVA	4.1 ENDOPORE® External Connection, 4.0 ENTEGRATM External Connection
OIC	3.0 Osteo Standard ST, 3.25 Osteo Standard ST, 3.75 Osteo Standard ST
MIS IMPLANTS	3.3mm Internal Hex, 3.75mm Internal Hex, 4.20mm Internal Hex, 5.0mm Internal Hex
BioHorizons®	3.5 Internal, 4.0 Internal, 4.5 Internal, 3.5 Single Stage, 4.5 Single Stage
Implant Direct	Legacy 3.5mm, Legacy 4.5mm, RePlant™ 4.3mm, RePlant™ 3.5mm, 3.7mm ScrewPlant, 4.7mm

Sterngold Dental, LLC Abbreviated 510(k) Premarket Notification

	ScrewPlant
Minimatic/Stryker	3.3 External Hex Cylinder, 3.75 External Hex Screw, 4.0 External Hex Cylinder, 4.0 External Hex
Minimatic/Stryker	Screw, 4.75 External Hex Screw, 5.0 External Hex Cylinder
Straumann	Straumann Bone Level RC, Blue Sky Bio Square Taper RC
Straumann	Straumann Bone Level NC, Blue Sky Bio Square Taper NC
Ankylos	Ankylos
Nobel Biocare	Nobel Replace WP, Nobel Replace Select WP, NobelSpeedy Replace WP, Implant Direct 5.0
Nobel Biocare	RePlant, BlueSky Bio 5.0 Trilobe
Nobel Biocare	Nobel Conical Connection RP
Nobel Biocare	Nobel Conical Connection NP, Blue Sky Bio Max
Astra Dental	Astra 4.5 / 5.0, Blue Sky Bio Conus 12 4.5 / 5.0
Astra Dental	Astra 3.5 / 4.0, Blue Sky Bio Conus 12 3.5 / 4.0
Zimmer Dental	Zimmer TSV 5.7mm, Implant Direct Legacy 5.7, BioHorizon 5.7

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Part 21 CFR 801 Subparts D) AND/OR

· Over-the -Counter Use (21 CFR 807 Subpart D)

Sheena A. Green-S
2014.04.16 11:34:03 -04'00'