The Promimic AB, Promimic Dental Implant is intended for surgical placement into the bone of upper/ lower jaw arches as a permanent anchorage for prosthetic devices and to restore chewing function. The Promimic Dental Implant can be immediately loaded only with good primary stability and appropriate occlusal loading. The Promimic Dental Implants are only to be used with straight abutments.

Device Description

The Promimic Dental Implant consists of 4 implants, diameter 3.75 mm, and length from 8.5 to 15.0 mm.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Promimic Dental Implant, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state quantitative "acceptance criteria" for the Promimic Dental Implant's performance. Instead, it uses a substantial equivalence (SE) approach, comparing its characteristics to previously cleared predicate devices. The "acceptance" is based on demonstrating that the new device's technological characteristics are similar to the predicates and that any differences do not raise new questions of safety or effectiveness.

Characteristic	Acceptance Criteria (Implied by Predicate Comparison)	Promimic Dental Implant Performance (Reported and Compared)
Indication for Use	Surgical placement into upper/lower jaw arches as permanent support for prosthetic attachment, to restore masticatory function.	Surgical placement into upper/lower jaw arches as permanent support for prosthetic attachment, to restore masticatory function.
Dimensions	Similar range to predicates (e.g., diameters 3.25-6 mm, lengths 8-19 mm)	Diam. 3.75 mm, length 8.5 - 15 mm
Material	Commercially pure Titanium or Ti alloy grade 5	Commercially pure Titanium
Threaded	Yes	Yes
Surface	Various surface treatments (e.g., Plasma sprayed HA, Anodized Ti, Ti blasted)	Spin coated nanometer scale HA
Surgical Technique	One - two stage	One - two stage
Sterilization Method	Radiation	Radiation
Abutment Connection	Various types (e.g., External hex, Internal trilobe, Conical internal)	External hex
Abutment Screw	M2 or similar for compatible platforms	M2
Mechanical Properties	In accordance with "Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, dated May 12, 2004" guideline.	In accordance to the guideline (no specific values given, but stated to be in conformity)

2. Sample Size Used for the Test Set and Data Provenance

The document does not report specific sample sizes for a "test set" in the context of clinical or performance data for the Promimic Dental Implant itself. The performance testing mentioned refers to mechanical testing, not clinical trials on human subjects.
The data provenance pertains to mechanical testing performed by Promimic AB to demonstrate the physical properties of the device. There's no mention of country of origin for clinical data or whether it's retrospective or prospective, as clinical data for this specific device is not presented.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable or not provided in the context of this 510(k) summary. The "ground truth" for showing substantial equivalence relies on comparing the device's technical specifications and mechanical testing results to established predicate devices and recognized standards, not on expert adjudication of clinical outcomes for a test set.

4. Adjudication Method for the Test Set

This information is not applicable or not provided. There is no mention of a clinical "test set" requiring adjudication by experts.

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

This is not applicable. The Promimic Dental Implant is a physical medical device (dental implant), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance would not be relevant.

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

This is not applicable. As stated, this is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the substantial equivalence determination is the technical specifications and established performance characteristics of legally marketed predicate devices and compliance with recognized mechanical testing guidelines (specifically, "Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, dated May 12, 2004").

8. The Sample Size for the Training Set

This information is not applicable or not provided. There is no "training set" in the context of developing this physical medical device. The manufacturing processes and design are based on established engineering principles and materials science.

9. How the Ground Truth for the Training Set was Established

This information is not applicable or not provided. There is no "training set" or corresponding ground truth for this type of device submission.

Summary

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K101225

SECTION 2. SUMMARY AND CERTIFICATION

JAN 2 5 2011

A. 510(k) SUMMARY

Summary of Safety and Effectiveness

In accordance with 21 CFR 807.92, the following information constitutes the Promimic AB summary for the Promimic Dental Implant.

SUBMITTER'S NAME:	Promimic AB
ADDRESS:	Stena Center 1BSE-41292 GöteborgSweden
CONTACT PERSON:TELEPHONE NUMBER:	Karin Breding+46 (0) 31 7728035
FAX NUMBER:	+46 (0) 31 7728091
DATE OF SUBMISSION:	April 30, 2010

1. Identification of device

Proprietary Name: Endosseous Implant and Abutment Common Name: Promimic Dental Implant Classification Status: Class II per regulations 872.3640 Product Codes: DZE

2. Equivalent devices

		Promimic AB believes the Promimic Dental Implant is substantially equivalent to:
K073161	Implant Direct Inc	Replus Dental Implants (HA)
K062432	Implant Innovation Inc	NanoTite Dental Implants
K925765	Nobelpharma USA Inc	Brånemark System Standard 3.75 mm Fixture
K991053fixtures (micromacro)	Astra Tech Inc	Astra Tech Implants- Dental system: New

3. Description of the Device

The Promimic Dental Implant consists of 4 implants, diameter 3.75 mm, and length from 8.5 to 15.0 mm.

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4. Intended use

The Promimic AB, Promimic Dental Implant is intended for surgical placement into the bone of upper /lower jaw arches as a permanent anchorage for prosthetic devices and to restore chewing function. The Promimic Dental Implant can be immediately loaded only with good primary stability and appropriate occlusal loading. The Promimic Dental Implants are only to be used with straight abutments.

Promimic Dental Implants are compatible with the following abutment system:

510(k) K910611	CeraOne Abutment System	Nobelphama
510(k) K944964	MirusCone Abutment System	Nobel Biocare
510(k) K961728	MirusCone Abutment System	Nobel Biocare
510(k) K971706	TiAdapt Abutment System	Nobel Biocare

Technological characteristics, comparison to predicate device. ನ.

The Promimic device is designed according to the long recognised principles of Professor Per-Ingvar Brånemark. The two-part titanium implant with a screw-shaped cylindrical fixture was introduced into clinical practice in 1965 and is at present commercially available in a large number of varieties provided by a large number of manufacturers. It is fair to state that this kind of implant has reached the status of a generic commodity.

The Promimic Dental Implants are manufactured by machining unalloyed titanium grade 4. This material has a long record as a standard material for surgical implants. The surfaces of the implantable parts are prepared by turning and milling, and the fixture surface is, in addition, subjected to a chemical process designed to yield a controlled surface chemistry, consisting out of hydroxyapatite crystals.

Characteristic	Promimic DentalImplant	Replus DentalImplants (HA)IMPLANTDIRECT LLC	NanoTite DentalImplants, Biomet3I	BRÅNEMARKSYSTEMSTANDARD ·3.75MMFIXTURE,NOBELPHARMAUSA, INC.	ASTRA TECHIMPLANTS -DENTALSYSTEM: NEWFIXTURES(MICROMACRO), ASTRA TECH	SE
Indication foruse	Surgical placementinto upper/lowerjaw arches aspermanent supportfor prostheticattachment, torestore masticatoryfunction.	Surgicalplacement intoupper/lower jawarches aspermanent supportfor prostheticattachment, torestoremasticatoryfunction.	Surgicalplacement intoupper/lower jawarches aspermanentsupport forprostheticattachment, torestoremasticatoryfunction.	Surgicalplacement intoupper/lower jawarches aspermanentsupport forprostheticattachment, torestoremasticatoryfunction.	Surgicalplacement intoupper/lower jawarches aspermanentsupport forprostheticattachment, torestoremasticatoryfunction.	Yes
Dimensions	Diam. 3.75 mmlength 8,5 - 15mm	Diam. 3.7-5.7mm, length 8-16mm	Diam. 3.25-6mmLength 8.5 -18mm	Diam. 3.3, 3.75, 4,0, 5.0 mmLength 7, 10, 13,15 mm	Diam. 3.5 and 4.0mmLength 8-19 mm	Yes
Material	Commerciallypure Titanium	Ti alloy grade 5	Ti alloy grade 5	Cp titanium	Cp titanium	Yes

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Threaded	Yes	Yes	Yes	Yes	Yes	Yes
Surface	Spin coatednanometer scaleHA	Plasma sprayedHA	A nanometer-scale discretecrystallinedeposition(DCDTM)of calciumphosphate (CaP)	Anodized Ti	Ti blasted	Yes
SurgicalTechnique	One - two stage	One- two stage	One- two stage	One- two stage	One- two stage	Yes
SterilizationMethod	Radiation	Radiation	Radiation	Radiation	Radiation	Yes
Abutmentconnection	External hex,	Internal trilobe	External hex,and internalconnection	External hex,	Conical internal	Yes
Abutmentscrew	M2	-tri rex I!L55	M2 for 3,75 mmimplants	M2 for Regularplatform implant	N/A	Yes
510(k)	No number yet	K073161	K062432	K925765	K991053

6. Discussion of performance testing.

Promimic has used the guideline "Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, dated May 12, 2004" regarding which test that should be performed regarding mechanical testing. As fatigue test are not performed on the implants they should not be used with angulated abutments. The Promimic Dental Implants are only to be used with straight abutments.

The mechanical properties and performed mechanical testing of the Promimic Dental Implant are in accordance to the above mentioned guideline and the system is generic to predicated previously marketed similar system. We have therefore come to the conclusion that additional testing would not raise issues of new or unidentified issues that would raise additional questions of safety and efficacy.

7. Conclusion

Based on comparison to the predicate device, Promimic Dental Implant is substantially equivalent to previously cleared predicate systems and presents no new concerns about safety and effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of a human figure with three arms or lines extending upwards, representing health and growth. The overall design is simple and symbolic, representing the department's mission to protect the health of all Americans.

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

Ms. Karin Breding Promimic AB Stena Center 1B SE-41292 Goteborg Sweden

JAN 2 5 2011

Re: K101225

Trade/Device Name: Promimic AB, Promimic Dental Implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Implant and Abutment Regulatory Class: II Product Code: DZE Dated: January 21, 2011 Received: January 24, 2011

Dear Ms. Breding:

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. Begister. Begister

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Page 2- Ms. Breding

Enclosure

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 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.

Sincerely yours,

for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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B. INDICATIONS FOR USE

510(k) Number K101225

Device Name: Promimic AB, Promimic Dental Implant.

Indications for Use:

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over the Counter Use

Susan Ryan

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Seneral on Control Dental Devices (Division Sign-Off) Division of Anesthesistory, Dental Devices
Infection Control, Dental Devices

Infection Cente
510(k) Number: K101225

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.