(531 days)
No
The device description and performance studies focus on the mechanical and material properties of the dental implant system, with no mention of AI or ML.
No.
A therapeutic device is one that treats or heals a disease or condition. This device is a dental implant system used for tooth replacement in edentulous sites, which is a restorative rather than therapeutic function.
No
The device description indicates that the Proximerge™ 2 Dental Implant System is an integrated system of endosseous dental implants, abutments, temporary abutments, and closure screws. These components are used for single tooth replacement and are "press-fit into the bone." This describes a therapeutic or reconstructive device, not a diagnostic one that identifies or characterizes a disease or condition. The performance studies also focus on mechanical and biological safety testing, not diagnostic accuracy.
No
The device description explicitly details physical components made of Ti-6A1-4V ELI, such as implants, abutments, and screws, indicating it is a hardware device, not software-only.
Based on the provided information, the Proximerge™ 2 Dental Implant System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Proximerge™ 2 Function: The description clearly states that the Proximerge™ 2 Dental Implant System is an integrated system of dental implants and related components designed for surgical implantation into the jawbone to replace missing teeth.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze any biological specimens. Its function is purely mechanical and structural within the body.
Therefore, the Proximerge™ 2 Dental Implant System falls under the category of a medical device used for surgical implantation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Proximerge™ 2 Dental Implant System is designed for use in edentulous sites in the mandible or maxilla as a single tooth replacement. These implants are indicated for delayed loading.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The Proximerge 2™ Dental Implant System is an integrated system of endosseous dental implants with corresponding abutments, temporary abutments, and closure screws. The implants are designed with elongation in the mesial-distal dimension. The implants have a 7mm length and a mesial-distal elongated footprint in 4.5x6.3mm, 4.5x7.6mm, 4.5x9.1mm, and 4.5x10.5mm options and are press-fit into the bone. The abutments have a 0° angulation, have post and gingival heights of 4.5mm and 2.4mm respectively for each implant size, and have a tapered implant-abutment interface . Temporary tissue former abutments (also called healing abutments) and healing caps are offered to protect the implant until the abutment is attached; the tissue formers and healing caps have the same angulation and implant-abutment interface as the permanent abutments. An M1.8 capture screw attaches the abutment, the tissue forming abutment, or the healing cap to the implant. All components in the Proximerge™ 2 Dental Implant System are manufactured from Ti-6A1-4V ELI per ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
edentulous sites in the mandible or maxilla
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)
The Proximerge™ 2 Dental Implant System has been tested in the following test modes:
- Static axial compression bending
- Dynamic axial compression bending per ISO 14801
- SEM EDS Spectroscopy Analysis of surface treatment
- Sterilization validation per ISO 11135
- Bacterial endotoxin testing per ANSI/AAMI ST72
- Packaging stability testing
- Bacterial filtration efficiency per ASTM F2101
- Blister integrity validation per ASTM F88, F1886, and F1229
- Cytotoxicity testing per ISO 10993-5
- EO Residuals testing per ISO 10993-7 .
The results of this non-clinical testing show that the Proximerge™ 2 Dental Implant System is sufficient for its intended use and is substantially equivalent to the predicate device.
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.
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.
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
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Quadric BioMed, LLC % Nathan Wright Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K211409
Trade/Device Name: Proximerge™ 2 Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: September 16, 2022 Received: September 19, 2022
Dear Nathan Wright:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
542 of the Act); 21 CFR 1000-1050.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.
510(k) Number (if known) K211409 Device Name
Proximerge™ 2 Dental Implant System Indications for Use (Describe)
The Proximerge™ 2 Dental Implant System is designed for use in edentulous sites in the mandible or maxilla as a single tooth replacement. These implants are indicated for delayed loading.
| 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) |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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K211409 - 510(K) SUMMARY
| Submitter's Name: | Quadric BioMed, LLC |
|---|---|
| Submitter's Address: | 640 Southpointe Court #150 |
| Colorado Springs, CO 80906 | |
| Submitter's Telephone: | 719-270-0755 |
| Contact Person: | Nathan Wright MS |
| Empirical Testing Corp. | |
| 719-351-0248 | |
| nwright@empiricaltech.com | |
| Image: EMPIRICAL TESTING CORP logo | |
| Date Summary was Prepared: | October 19, 2022 |
| Trade or Proprietary Name: | Proximerge™ 2 Dental Implant System |
| Common or Usual Name: | Endosseous dental implant |
| Classification: | Class II per 21 CFR §872.3640 |
| Product Code: | DZE, NHA |
| Classification Panel: | Dental |
PREDICATE DEVICE INFORMATION
The subject device in this submission is substantially equivalent in indications, intended use, and design principles to the following predicate and reference devices:
| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Predicate Type |
|---|---|---|---|
| K092035 | Bicon Implants with a 2.5mm Internal Connection | Bicon, LLC | Primary Predicate |
| K972417 | 6.0 x 8.0mm Dental Implant System | Bicon, Inc. | Reference Device |
| K171784 | Straumann Dental Implant System | Straumann USA, LLC | Reference Device |
| K201334 | Keystone Dental XL Dental Implant System | Keystone Dental Inc. | Reference Device |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Proximerge 2TM Dental Implant System is an integrated system of endosseous dental implants with corresponding abutments, temporary abutments, and closure screws. The implants are designed with elongation in the mesial-distal dimension. The implants have a 7mm length and a mesial-distal elongated footprint in 4.5x6.3mm, 4.5x7.6mm, 4.5x9.1mm, and 4.5x10.5mm options and are press-fit into the bone. The abutments have a 0° angulation, have post and gingival heights of 4.5mm and 2.4mm respectively for each implant size, and have a tapered implant-abutment interface . Temporary tissue former abutments (also called healing abutments) and healing caps are offered to protect the implant until the abutment is attached; the tissue formers and healing caps have the same angulation and implant-abutment interface as the permanent abutments. An M1.8 capture screw attaches the abutment, the tissue forming abutment, or the healing cap to the implant. All components in the Proximerge™ 2 Dental Implant System are manufactured from Ti-6A1-4V ELI per ASTM F136.
INDICATIONS FOR USE
The Proximerge™ 2 Dental Implant System is designed for use in edentulous sites in the mandible or maxilla as a single tooth replacement. These implants are indicated for delayed loading.
4
TECHNOLOGICAL CHARACTERISTICS
The subject and predicate devices have similar technological characteristics and the minor differences of safety and effectiveness. The following is a comparison between the subject and predicates:
| | Quadric BioMed, LLC
Proximerge™ 2 Dental
Implant System (Subject
Device) | Bicon Implants with a 2.5mm
Internal Connection
(K092035) | Bicon 6.0 x 8.0mm Dental
Implant System
(K972417) | Straumann Dental Implant System
(K171784) | Keystone Dental Inc. Keystone
Dental XL Dental Implant
System (K201334) | Comparison |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | The Proximerge™ 2 Dental
Implant System is designed for
use in edentulous sites in the
mandible or maxilla as a single
tooth replacement. These
implants are indicated for
delayed loading. | The Bicon implant is designed for
use in edentulous sites in the
mandible or maxilla for support of
a complete denture prosthesis, a
final or intermediate abutment for
fixed bridgework or for partial
dentures, or as a single tooth
replacement. | The 6.0 x 8.0mm implant is
designed for use in edentulous
sites in the mandible or maxilla
for support of a complete
denture prosthesis, a terminal or
intermediate abutment for fixed
bridgework, partial dentures, or
a single tooth replacement. | Straumann® Dental implants are
indicated for oral endosteal
implantation in the upper and lower
jaw arches and for the functional and
aesthetic oral rehabilitation of
edentulous and partially dentate
patients. Straumann® Dental implants
are also indicated for immediate or
early implantation following extraction
or loss of natural teeth. Implants can be
placed with immediate function on
single-tooth and/or multiple-tooth
applications when good primary
stability is achieved and with
appropriate occlusal loading to restore
chewing function. The prosthetic
restorations used are single crowns,
bridges and partial or full dentures,
which are connected to the implants
through the corresponding components
(abutments). | The XL Dental Implant System is
intended for implantation in the
maxillary or mandibular
molar region where bone exists and
the surgeon has determined that the
placement of a narrower diameter
implant would increase the
probability of failure due to poor
primary stability, or increased
surgical procedures leading to
complications. This XL implant
system provides support for fixed or
removable dental prostheses in a
single tooth, partially edentulous
prostheses or full arch prostheses. It
further adds the option for
immediate loading on single and
splinted multiple unit restorations
when good primary stability is
achieved and with appropriate
occlusal loading, to restore chewing
function. | Subject indications are similar to the
indications of K092035 and K972417.
The predicate and reference devices
are for delayed loading as well but did
not specify so in their indications for
use statement. The predicate and
reference devices offer additional
applications such as support for
denture and bridgework prostheses that
the subject does not seek to indicate.
The subject indications are similar to
those of K171784 and K201334 but
those reference devices are intended
for both immediate and delayed
loading and include additional
indications not covered by subject. |
| Product Code: | DZE, NHA | DZE | DZE | DZE | DZE, NHA | Same. The predicate and all reference
devices include abutments but some
were cleared with only the DZE
product code without the abutment
product code NHA. |
| Purpose for being referenced: | | This device was made the primary
predicate because of its
technology for which the subject
is similar in indications, material,
press-fit implantation style, some
sizes, surface treatment, and
abutments. | This device is included as a
reference device to show that
subject bone contact surface area
is larger than that of a cleared
predicate. | This predicate was included for a
comparison of the subject's
mechanical performance to that of a
cleared predicate and for additional
abutment size comparisons. | This predicate has been included so
that the envelope of subject implant
footprints is not outside the range of
cleared and for additional abutment
size comparisons. | |
| Materials: | Ti-6Al-4V ELI per ASTM F136 | Ti-6Al-4V or CP Titanium | CP Titanium | CP Titanium, titanium-zirconium alloy | Titanium Alloy per ASTM F136 | Same as K201334. |
| Implant Sizes: | Length: 7mm | Length: 5, 6, 8, 11mm | Length: 8mm | Length: 6mm to 18mm | Length: 7mm, 9mm, 11mm | The subject implant length of 7mm
falls within the envelope of lengths of
cleared predicate implants. |
| | Footprint (Elongated):
Size 4.5x6.3 mm Implant
(24.0mm2 cross-sectional area)
Size 4.5x7.6 mm Implant (29.9
mm2 cross-sectional area)
Size 4.5x9.1 mm Implant (36.6
mm2 cross-sectional area)
Size 4.5x10.5mm Implant (42.9
mm2 cross-sectional area)
Note: The subject implant
footprint measurement is the
buccal-lingual width by mesial-
distal length. All predicates have | Footprint (Round):
Ø4mm (12.6 mm2 cross-sectional
area)
Ø4.5mm (15.9 mm2 cross-
sectional area) | Footprint (Round): Ø6mm (28.3
mm2 cross-sectional area) | Footprint (Round): 8.6mm2 (Ø3.3mm)
to 18.1mm2 (Ø4.8mm) | Footprint (Round): 38.5mm2
(Ø7mm), 50.3mm2 (Ø8mm),
63.6mm2 (Ø9mm) | The subject implant has an elongated
shape while the predicate implants
have round shapes. This difference
does not affect the substantial
equivalence of the subject device
because sufficient residual bone is
present on all side of the implant.
The subject implant footprint cross-
sectional area envelope falls within the
envelope of predicate footprint areas.
The subject ranges from 24.0mm2 to
42.9mm2. Predicate and reference
implant footprint cross-sectional area
ranges from 8.6mm2 to 63.6mm2. |
| | Quadric BioMed, LLC
Proximerge™ 2 Dental
Implant System (Subject
Device) | Bicon Implants with a 2.5mm
Internal Connection
(K092035) | Bicon 6.0 x 8.0mm Dental
Implant System
(K972417) | Straumann Dental Implant System
(K171784) | Keystone Dental Inc. Keystone
Dental XL Dental Implant
System (K201334) | Comparison |
| | a round footprint with the
diameter measurement listed. | | | | | |
| Implant Surface
Treatment: | Grit blasted with Hydroxyapatite
and acid etching | Grit blasted with Hydroxyapatite
and acid etching | Grit blasted with Hydroxyapatite
and acid etching | Grit-blasted and acid-etched | Grit blasted and acid etched | Same surface treatment as K092035
and K972417. |
| Implantation
Method: | Press fitting of ridged shaft into
the bone. | Press fitting of ridged shaft into
the bone. | Press fitting of ridged shaft into
the bone. | Driving torque of threaded shaft into
the bone. | Driving torque of threaded shaft
into the bone. | Same method of implantation as
K092035 and K972417. |
| Abutment: | Angulation: 0° | Angulation: 0°, 15° | Angulation: 0°, 15° | Angulation: 0°, 15° | Angulation: 0° | The subject abutments angulation is
within the range of the predicate
device. |
| | Abutment Footprint: Elongated
with Cross-Sections of 31.2 mm²
(for 4.5x6.3 abutment), 44.4
mm² (for 4.5x7.6 abutment),
55.5 mm² (for 4.5x9.1 abutment,
65.8 mm² (for 4.5x10.5
abutment) | Abutment Footprint: Round with
Cross-Section of 12.6 mm²
(Ø4mm abutment) and 15.9 mm²
(Ø4.5mm abutment) | | Abutment Footprint: Round with
Cross-Section of 8.6 mm² (Ø3.3mm
abutment), 13.2 mm² (Ø4.1mm
abutment), and 18.1 mm² (Ø4.8mm
abutment) | Abutment Footprint: Round with
maximum Cross-Section of 63.6
mm² (Ø9mm) | The subject abutment's footprint area
envelope is within the range of the
predicate and reference devices. The
subject abutment has a minimum
footprint cross-sectional area of 31.2
mm² while the Bicon abutments are as
small as Ø4mm (12.6 mm²). The
subject abutment has a maximum
footprint cross-section of 65.8 mm²
while the Keystone XL abutments are
up to 63.6 mm² in cross-section which
is approximately the same. The
elongated footprint of the subject
compared to the predicate round
footprint has been justified based on
the implant shape. Mechanical testing
showed that the differences in footprint
at the implant-abutment interface does
not affect the substantial equivalence
of the device. |
| | Post Height: 4.5mm | Post Height not publicly available | Post Height not publicly
available | Post Height not publicly available | Post Height not publicly available | The subject has a post height of
4.5mm; a minimum post height of 4
mm is typical for FDA cleared
abutments. |
| | Gingival Height: 2.4mm | Gingival Height not publicly
available | Gingival Height not publicly
available | Gingival Height: 1mm – 6mm | Gingival Height 1mm, 3mm | The subject abutment gingival height
falls within the reference device
(K171784 and K201334) envelope of
gingival heights. |
| | Implant Connection: Internal
taper fit (with screw) | Implant Connection: Internal taper
fit | Implant Connection: Internal
taper fit (with screw) | Implant Connection: Internal taper fit
and internal octagon (with screw) | Implant Connection: Internal taper
fit (with Ti-6Al-4V screw) | The subject and the predicate and
reference devices have an internal
tapered fit implant-abutment
connection with screw. |
| Tissue Former (or
Healing Abutment): | Collar height of 4.9 with collar
diameter/footprint cross-section
of 31.2 mm², 44.4 mm², 55.5
mm², and 65.8 mm². | Sizes not publicly available. | Sizes not publicly available. | Collar height from 1mm to 6mm with
collar cross-section from ≈ 14.2 mm²
(3.3x4.3 oval) to 33.2 mm² (Ø6.5mm). | Collar heights of 1mm and 3mm
with collar cross-section from 38.5
mm² (Ø7 mm) to 63.6 mm² (Ø9
mm). | The subject healing abutments falls
approximately within the envelope of
reference device (K171784 and
K201334) healing abutment collar
heights and collar cross-sections. |
| Healing Cap: | Gingival height of 0 mm with
diameter/footprint cross-section
of 10.6 mm², 17.1 mm², 21.8
mm², and 26.1 mm². | Sizes not publicly available. | Sizes not publicly available. | Sizes not publicly available. | Sizes not publicly available. | The healing cap is a temporary non-
load bearing component that shields
the implant until the permanent
abutment is attached. The healing cap
is designed uniquely to the subject |
| | Quadric BioMed, LLC Proximerge™ 2 Dental Implant System (Subject Device) | Bicon Implants with a 2.5mm Internal Connection (K092035) | Bicon 6.0 x 8.0mm Dental Implant System (K972417) | Straumann Dental Implant System (K171784) | Keystone Dental Inc. Keystone Dental XL Dental Implant System (K201334) | Comparison |
| | | | | | | implant geometry. Difference in geometry relative to the predicate and reference devices do not affect the performance of the subject system. |
| Abutment Surface Treatment: | No surface treatment | No surface treatment. | No surface treatment. | Surface treatment unknown. | Surface treatment unknown. | Same as K092035 and K972417 |
| Implant & Abutment Sterilization: | Provided sterile via EO Sterilization | Sterility unknown. | Sterility unknown. | Provided sterile via Gamma Sterilization | Provided sterile via Gamma Sterilization | The subject and reference devices are provided Sterile to the end user. The identified reference devices are gamma sterilized while the subject is EO sterilized. This difference does not affect the sterility of the device because the sterilization method was validated per ISO 11135 to a sterility assurance level (SAL) of 10-6. |
Quadric BioMed, LLC Proximerge 2 Dental Implant System
5
Quadric BioMed, LLC Proximerge 2 Dental Implant System
6
7
Performance Data
The Proximerge™ 2 Dental Implant System has been tested in the following test modes:
- Static axial compression bending ●
- Dynamic axial compression bending per ISO 14801 ●
- SEM EDS Spectroscopy Analysis of surface treatment ●
- . Sterilization validation per ISO 11135
- Bacterial endotoxin testing per ANSI/AAMI ST72
- Packaging stability testing ●
- o Bacterial filtration efficiency per ASTM F2101
- o Blister integrity validation per ASTM F88, F1886, and F1229
- Cytotoxicity testing per ISO 10993-5 ●
- EO Residuals testing per ISO 10993-7 .
The results of this non-clinical testing show that the Proximerge™ 2 Dental Implant System is sufficient for its intended use and is substantially equivalent to the predicate device.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Proximerge™ 2 Dental Implant System is substantially equivalent to the predicate device.