PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 8.5 MM MODEL 03-1001, PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 10 MM MODEL 03-1

Q: Who is the manufacturer of PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 8.5 MM MODEL 03-1001, PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 10 MM MODEL 03-1?

Promimic AB filed the 510(k) submission for PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 8.5 MM MODEL 03-1001, PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 10 MM MODEL 03-1 (K101225).

Q: What is the FDA product code for PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 8.5 MM MODEL 03-1001, PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 10 MM MODEL 03-1?

DZE. It is classified under 21 CFR 872.3640 as a Class 2 device in the Dental panel.

Q: What is the regulatory pathway for PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 8.5 MM MODEL 03-1001, PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 10 MM MODEL 03-1?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 8.5 MM MODEL 03-1001, PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 10 MM MODEL 03-1?

Replus Dental Implants (HA) (K073161); NanoTite Dental Implants (K062432); Brånemark System Standard 3.75 mm Fixture (K925765); Astra Tech Implants- Dental system: New (K991053).

Q: Who can help prepare an FDA 510(k) submission like PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 8.5 MM MODEL 03-1001, PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 10 MM MODEL 03-1?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K101225 · Promimic AB · DZE · Jan 25, 2011 · Dental

Device Facts

Record ID	K101225
Device Name	PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 8.5 MM MODEL 03-1001, PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 10 MM MODEL 03-1
Applicant	Promimic AB
Product Code	DZE · Dental
Decision Date	Jan 25, 2011
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3640
Device Class	Class 2
Attributes	Therapeutic

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.

Device Story

Endosseous dental implant system; consists of four titanium implants (3.75 mm diameter; 8.5-15.0 mm length). Designed for surgical placement into upper/lower jaw bone; provides permanent anchorage for prosthetic devices; restores chewing function. Features spin-coated nanometer-scale hydroxyapatite surface. Used in clinical dental settings by trained professionals. Requires straight abutments; supports immediate loading if primary stability and occlusal conditions are met. Benefits patient by providing stable foundation for dental prosthetics.

Clinical Evidence

Bench testing only. Mechanical testing performed per FDA guidance 'Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments' (May 12, 2004). No clinical data provided.

Technological Characteristics

Material: Commercially pure titanium (Grade 4). Surface: Spin-coated nanometer-scale hydroxyapatite crystals. Form factor: Two-part screw-shaped cylindrical fixture; 3.75 mm diameter; 8.5-15.0 mm length. Connection: External hex. Sterilization: Radiation. Mechanical testing performed per FDA guidance.

Indications for Use

Indicated for surgical placement into upper or lower jaw bone to provide permanent anchorage for prosthetic devices and restore chewing function in patients requiring dental implants. Contraindicated for use with angulated abutments.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Replus Dental Implants (HA) (K073161)
NanoTite Dental Implants (K062432)
Brånemark System Standard 3.75 mm Fixture (K925765)
Astra Tech Implants- Dental system: New (K991053)

Reference Devices

CeraOne Abutment System (K910611)
MirusCone Abutment System (K944964)
MirusCone Abutment System (K961728)
TiAdapt Abutment System (K971706)

Related Devices

K172240 — SPI Dental Implant System · Msi France · Jan 31, 2018
K180598 — UNIQA Dental Implants System · Uniqa Dental, Ltd. · Aug 8, 2018
K071161 — ENDOSSEOUS DENTAL IMPLANT SYSTEM · Southern Implants, Inc. · Nov 16, 2007
K143539 — Dental Implant OKTAGON Bone Level · Hager& Meisinger GmbH · Aug 31, 2015
K242217 — Surcam Dental Implant System · Surcam Medical Devices and Developments, Ltd. · Jan 29, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ 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 1B SE-41292 Göteborg Sweden | | 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 | | K991053 fixtures (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. {1}------------------------------------------------ #### 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 Dental Implant | Replus Dental Implants (HA) IMPLANT DIRECT LLC | NanoTite Dental Implants, Biomet 3I | BRÅNEMARK SYSTEM STANDARD · 3.75MM FIXTURE, NOBELPHARMA USA, INC. | ASTRA TECH IMPLANTS - DENTAL SYSTEM: NEW FIXTURES (MICROMACRO) , ASTRA TECH | SE | |-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-----| | 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. | 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. | Surgical placement into upper/lower jaw arches as permanent support for prosthetic attachment, to restore masticatory function. | Yes | | Dimensions | Diam. 3.75 mm length 8,5 - 15 mm | Diam. 3.7-5.7 mm, length 8-16 mm | Diam. 3.25-6 mm Length 8.5 -18 mm | Diam. 3.3, 3.75, 4,0, 5.0 mm Length 7, 10, 13, 15 mm | Diam. 3.5 and 4.0 mm Length 8-19 mm | Yes | | Material | Commercially pure Titanium | Ti alloy grade 5 | Ti alloy grade 5 | Cp titanium | Cp titanium | Yes | {2}------------------------------------------------ | Threaded | Yes | Yes | Yes | Yes | Yes | Yes | |-------------------------|--------------------------------------|----------------------|---------------------------------------------------------------------------------------------------------|------------------------------------|------------------|-----| | Surface | Spin coated nanometer scale HA | Plasma sprayed HA | A nanometer- scale discrete crystalline deposition (DCDTM) of calcium phosphate (CaP) | Anodized Ti | Ti blasted | Yes | | Surgical Technique | One - two stage | One- two stage | One- two stage | One- two stage | One- two stage | Yes | | Sterilization Method | Radiation | Radiation | Radiation | Radiation | Radiation | Yes | | Abutment connection | External hex, | Internal trilobe | External hex, and internal connection | External hex, | Conical internal | Yes | | Abutment screw | M2 | -tri rex I!L55 | M2 for 3,75 mm implants | M2 for Regular platform 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. {3}------------------------------------------------ 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 {4}------------------------------------------------ ### 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 {5}------------------------------------------------ ## B. INDICATIONS FOR USE 510(k) Number K101225 Device Name: Promimic AB, Promimic Dental Implant. ### Indications for 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. (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) OR 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