(367 days)
No
The device description and performance studies focus on the chemical and physical properties of a dental adhesive, with no mention of AI or ML.
No.
The device is an adhesive used for bonding restorative materials to dental tissue, which is a structural and restorative function, not a therapeutic one aiming to treat a disease or condition.
No.
The device is an adhesive used for bonding restorative materials to dental tissue. Its intended uses and performance metrics (e.g., adhesive strength, shear bond strength) relate to its function as a bonding agent, not to diagnosing a medical condition.
No
The device description clearly states it is a "light-curing 5th generation adhesive" and a "single flask self-etch light-curing adhesive system," indicating it is a physical chemical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a dental adhesive for bonding restorative materials to tooth structure and for luting prosthetic pieces. This is a direct application to the patient's body (or a prosthetic intended for the body), not for testing samples taken from the body.
- Device Description: The description reinforces its function as a bonding agent for dental tissue.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the body (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
- Anatomical Site: The anatomical site is the oral cavity/tooth, which is a direct application site, not a source for diagnostic samples.
- Performance Studies: The performance studies focus on the physical and chemical properties of the adhesive and its bonding strength to dental tissue, not on diagnostic accuracy or analytical performance related to biological samples.
In summary, the device is a dental material used for restorative and prosthetic procedures, which falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
- All classes of direct restoration with composites (class I, II, III, IV and V);
- Adhesive luting (in addition to resin cement) of prosthetic pieces (post/cores, crowns, onlays/inlays, veneers etc.) made of fiberglass, ceromer, ceramic, resin and metal;
- Adhesive repairs in ceramic and composites.
Only for Ambar Universal APS: Use as metallic or ceramic primer.
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
Ambar APS is a light-curing 5th generation adhesive (two-step adhesive, total etch technique) for bonding restorative materials to dental tissue (enamel and/ or dentin). As the primer and the bonding agent are combined in a single bottle, acid etching is the only previous step needed before applying the adhesive to dentin and enamel.
Ambar Universal APS is a single flask self-etch light-curing adhesive system (Seventh Generation) responsible for the union between tooth structure (enamel and dentin) and restorative materials. The primer and bonding agent are combined in a single flask. Prior use of acid etchant is optional on both tooth 's enamel and dentin, it can be used, therefore, in three ways: self-etch, selective-etch and total-etch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral, tooth
Indicated Patient Age Range
No restriction, it can be applied to general population
Intended User / Care Setting
Dental prosthetics and authorized laboratories and clinics.
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)
Non-clinical testing was performed for:
- Adhesive Strength Testing on Dental Tissue: Comparative analysis between commercial adhesives and the adhesive under analysis. Acceptance criterion: subject adhesive mean >= competing adhesives. Results: Ambar APS: 38.61 ± 1.68 (MPa), Ambar Universal APS: 38.02 ± 3.33 (MPa). Subject devices are >= predicate devices.
- Test for determining the degree of conversion (gc): Comparative analysis between commercial adhesives and the adhesive under analysis. Acceptance criterion: subject adhesive mean >= competing adhesives. Results: Ambar APS: 53.8 ± 0.5, Ambar Universal APS: 55.80 ± 0.5. Subject devices are >= predicate devices.
- Test of Shear bond strength (ISO 29022: 2013): Comparative analysis between commercial adhesives and the adhesive under analysis. Acceptance criterion: subject adhesive mean >= competing adhesives. Results: Ambar APS: 22.21 ± 2.33 (MPa), Ambar Universal APS: 16.30 ± 1.67 (MPa). Subject devices are >= predicate devices.
- pH: Comparative analysis. Acceptance criterion: adhesive has low hydrogen potential as competing adhesives analyzed. Results: Ambar APS: 3.16 ± 0.02, Ambar Universal APS: 2.97 ± 0.04. Subject devices have lower hydrogen potential than predicate devices.
- Viscosity: Test conducted to attend the FDA requirement, not contemplated in regulations for adhesives. Results: Ambar APS: 81.33 ± 2.05 mPa.s, Ambar Universal APS: 99.20 ± 0.40 mPa.s.
- Water sorption: Follows ISO 4049 methodology. Acceptance criterion: results should be better or statistically equal to competitors. Results: Ambar APS: 140.80 ± 1.60 µg/mm3, Ambar Universal APS: 145.53 ± 3.12 µg/mm³. Subject devices show similar sorption to competing adhesives.
- Water solubility: Follows ISO 4049 methodology. Acceptance criterion: results should be better or statistically equal to competitors. Results: Ambar APS: 64.61 ± 1.86 µg/mm³, Ambar Universal APS: 64.71 ± 1.59 µg/mm³. Subject devices show similar solubility to competing adhesives.
- Accelerated Stability Studies: Study to accelerate possible chemical degradation. Results: Ambar APS has an estimated shelf life of 3 years at 30°C. Ambar Universal APS has an estimated shelf life of 2 years at 25°C.
- Evaluation Report of Long-Term Stability (Shelf): Study to verify physical and chemical characteristics during expected shelf life. Results: Ambar APS shelf life of 3 years at 30°C confirmed. Ambar Universal APS shelf life of 2 years at 30°C confirmed.
- Transport Evaluation: Study to verify physical and chemical characteristics during transport. Results: Product can be transported at temperatures between 50°C and -5°C.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Adhesive Strength: Ambar APS: 38.61 ± 1.68 (MPa), Ambar Universal APS: 38.02 ± 3.33 (MPa)
- Conversion rate: Ambar APS: 53.8 ± 0.5, Ambar Universal APS: 55.80 ± 0.5
- Shear bond strength: Ambar APS: 22.21 ± 2.33 (MPa), Ambar Universal APS: 16.30 ± 1,67 (MPa)
- pH: Ambar APS: 3.16 ± 0.02, Ambar Universal APS: 2.97 ± 0.04
- Viscosity: Ambar APS: 81.33 ± 2.05 mPa.s, Ambar Universal APS: 99.20 ± 0.40 mPa.s
- Water sorption: Ambar APS: 140.80 ± 1.60 µg/mm3, Ambar Universal APS: 145.53 ± 3.12 µg/mm3
- Water solubility: Ambar APS: 64.61 ± 1.86 µg/mm3, Ambar Universal APS: 64.71 ± 1.59 µg/mm3
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 13, 2019
DentsCare LTDA % Rodrigo Abreu Regulatory Specialist United Regulatory LLC 12343 NW 25th St Coral Springs, Florida 33065
Re: K183424
Trade/Device Name: Ambar, Ambar APS, Ambar Universal APS Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: November 11, 2019 Received: November 13, 2019
Dear Rodrigo Abreu:
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.
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
1
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 (OS) 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 531-542 of the Act); 21 CFR 1000-1050.
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 mediation-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,
for Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183424
Device Name Ambar APS and Ambar Universal APS
Indications for Use (Describe)
-
All classes of direct restoration with composites (class I, II, III, IV and V);
-
Adhesive luting (in addition to resin cement) of prosthetic pieces (post/cores, crowns, onlays/inlays, veneers etc.) made of fiberglass, ceromer, ceramic, resin and metal;
-
Adhesive repairs in ceramic and composites.
*Only for Ambar Universal APS: Use as metallic or ceramic primer.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CER 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo and contact information for DentsCare LTDA. The logo features a stylized letter 'D' with horizontal lines inside. The text includes the company name, address (AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL), and phone number (Ph: 55 - 47 - 3441-6131).
Section 5 510(k) SUMMARY
Revision date: December 12, 2019
- A) Submitter's Name: DENTSCARE LTDA
Owner / Operator Registration Number: 3007210751
Manufacture Registration Number: 3007210751
- B) Address: AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL
- C) Phone and Fax Numbers
Phone: +55 (47) 34416131
- D) Contact Person:
Roberta Uyara
Tel.: +55 (47) 34416131
- E) Preparation Date: December 12, 2019
- F) Classification Name: Resin tooth bonding agent
Common / Usual Name: Tooth Bonding Adhesive
Proprietary Name: Ambar APS and Ambar Universal APS
Product Code: KLE
Class: Class II
Regulation: 21 CFR 872.3200
G) Device Description
Ambar APS
Ambar APS is a light-curing 5th generation adhesive (two-step adhesive, total etch technique) for bonding restorative materials to dental tissue (enamel and/ or dentin). As the primer and the bonding agent are combined in a single bottle, acid etching is the only previous step needed before applying the adhesive to dentin and enamel.
Ambar Universal APS
Ambar Universal APS is a single flask self-etch light-curing adhesive system (Seventh Generation) responsible for the union between tooth structure (enamel and dentin) and restorative materials. The primer and bonding agent are combined in a single flask. Prior use of acid etchant is optional on both tooth 's enamel and dentin, it can be used, therefore, in three ways: self-etch, selective-etch and total-etch.
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Image /page/4/Picture/0 description: The image shows the logo and contact information for Dentscare Ltda. The logo features a stylized letter D with horizontal lines inside. The contact information includes the company's address: AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL, and phone number: Ph: 55 - 47 - 3441-6131.
H) Substantial Equivalence:
The Ambar APS and Ambar Universal APS are equivalent with the following products:
| 510(k) Number | Model | Company |
|---|---|---|
| K962785 | ||
| (primary predicate) | 3M Dent System (Single Bond 2) | 3M COMPANY |
I) Reference Devices:
| 510(k) Number | Model | Company | Indication for Use Comparison | |||
|---|---|---|---|---|---|---|
| K110302 | Adhesive EXL 759 (Single Bond Universal) | 3M COMPANY | Ambar APS and | |||
| Ambar Universal | ||||||
| APS | 3M Dent System | |||||
| (Single Bond 2) | Adhesive EXL 759 | |||||
| (Single Bond | ||||||
| Universal) | Adhese Universal | |||||
| (Tetric - N – Bond | ||||||
| Universal) | ||||||
| K133318 | Adhese Universal (Tetric – N – Bond | |||||
| Universal) | Ivoclar | Dentscare | 3M | |||
| (primary predicate) | 3M | Ivoclar | ||||
| - All classes of | ||||||
| direct restoration | ||||||
| with composites | ||||||
| (class I, II, III, IV | ||||||
| and V); | Direct light-cured | |||||
| composite/compomer | ||||||
| restorations | All classes of fillings | |||||
| (according to Black) | ||||||
| with light-curing | ||||||
| composite or | ||||||
| compomer filling | ||||||
| materials | Direct-placed light- | |||||
| curing composite and | ||||||
| compomer restorations | ||||||
| - Adhesive luting | ||||||
| (in addition to resin | ||||||
| cement) of | ||||||
| prosthetic pieces | ||||||
| (post/cores, | ||||||
| crowns, | ||||||
| onlays/inlays, | ||||||
| veneers etc.) made | ||||||
| of fiberglass, | ||||||
| ceromer, ceramic, | ||||||
| resin and metal; |
- Adhesive repairs
in ceramic and
composites.
*Only for Ambar
Universal APS: Use
as metallic or
ceramic primer. | Porcelain veneers
(when used with
RelyX™ Veneer
Cement)
Crown & bridge,
inlay/onlay, bonding
amalgam (when used
with RelyX™ ARC
Adhesive Resin
Cement) | Cementation of indirect
restorations (inlays,
onlays, crowns,
bridges, veneers) of
composite, compomer,
ceramic, and metal
when combined with
Suglue-10 Adhesive
Resin Cement,
manufactured by 3M ESPE
Cementation of veneers
when combined with
RelyX Veneer Cement,
manufactured by 3M ESPE
Bonding of core build-ups
made of light-curing
composite or core build-up
materials
Bonding of dual-cure
cements and core build-up
materials and self-cure
composites when combined
with Activator EXL 760 | Direct-placed core
build-ups with light-, self- and dual-curing composites
Adhesive cementation of indirect restorations with light- and dual- curing luting composites | | | |
| | Porcelain / composite
repair | Repair of composite or
compomer fillings
Intraoral repair of
composite restorations,
porcelain fused to
metal, and all-ceramic
restorations without
extra primer | Repair of fractured
composite and
compomer restorations. | | | |
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Image /page/5/Picture/0 description: The image shows the logo and contact information for DentsCare LTDA. The logo features a stylized letter 'D' with horizontal lines inside. The text includes the company name, address (AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL), and phone number (Ph: 55 - 47 - 3441-6131).
J) Indications for Use:
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Image /page/6/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter "D" in a gray color. Inside the "D" are three horizontal lines that resemble sound waves. Below the "D" is the text "DentsCare" in a sans-serif font, also in gray.
. EDGAR NELSON MEISTER, 474, JOINVILLE, ARINA 89219-501 BRAZIL Ph: 55 - 47 - 3441-6131
| Not indicated | Surface treatment of
porcelain, ceramics
(including glass
ceramics, zirconia and
alumina), metal and
composite | Not indicated |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Root surface
desensitization | Root surface
desensitization | Desensitization of
hypersensitive cervical
areas |
| Not indicated | Sealing of cavities prior
to cementation of
amalgamate
restorations
Sealing of cavities and
preparation of tooth
stumps prior to
temporary cementation
of indirect restorations | Sealing of prepared
tooth surfaces before
temporary / permanent
cementation of indirect
restorations |
| Not indicated | Bonding of fissure
sealants
Protective varnish for
glass ionomer fillings | Not indicated |
Discussion: The subject devices are adhesive systems that offer the dental professional a wide range of applications. The Ambar APS and Ambar Universal APS are substantially equivalent to the predicate device (Single Bond 2) and the reference devices (Single Bond Universal and Tetric – N – Bond Universal) above in that all are intended to be used as a 21 CFR 872.3200 resin tooth bonding agent. The subject devices are substantially equivalent to Single Bond 2 in terms of indications. Regarding the claim "Use as metallic or ceramic primer", the Ambar Universal APS it similar to the reference predicate, Single Bond Universal, that indicates the use for "Surface treatment of porcelain, ceramics (including glass ceramics, zirconia and alumina), metal and composite."
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Image /page/7/Picture/0 description: The image shows the logo and contact information for Dentscare LTDA. The logo features a stylized letter D with three horizontal lines inside. The text includes the company name, address (AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL), and phone number (Ph: 55 - 47 - 3441-6131).
K) Technological Characteristics Comparison:
The predicate device used to establish substantial equivalence for the Ambar APS and Ambar Universal APS device is outlined below. This submission will provide a comparison of design, materials, and technical specifications of the Ambar APS and Ambar Universal APS to each of the predicate devices stratified by functional modality.
| Device
Manufacturer
and Common
Name | Ambar APS
and Ambar
Universal APS
Dentscare | 3M Dent
System (Single
Bond 2)
3M
(primary predicate) | Adhesive EXL
759 (Single
Bond
Universal)
3M | Adhese
Universal
(Tetric - N -
Bond
Universal)
3M |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| 510k # | K183424 | K962785 | K110302 | K133318 |
| Classification | Class II | Class II | Class II | Class II |
| Regulation # | 21 CFR
872.3200 | 21 CFR 872.3200 | 21 CFR
872.3200 | 21 CFR
872.3200 |
| Product Code | KLE | KLE | KLE | KLE, LBH |
| Classification
Name | Resin tooth
bonding agent | Resin tooth
bonding agent | Resin tooth
bonding agent | Resin tooth
bonding agent |
| Patient
Population | No restriction,
it can be
applied to
general
population | No restriction, it
can be applied to
general
population | No restriction,
it can be
applied to
general
population | No restriction,
it can be
applied to
general
population |
| Prescription
Use | RX only | RX only | RX only | RX only |
| Environment | Dental
prosthetics and
authorized
laboratories
and clinics.
Must be stored
in
temperatures
from 5° to
30°C / 41° to
86°F. | Dental
prosthetics and
authorized
laboratories and
clinics.
It can be stored
at room
temperature. | Dental
prosthetics and
authorized
laboratories
and clinics.
It can be
stored at room
temperature. | Dental
prosthetics
and
authorized
laboratories
and clinics.
Store
conditions not
found. |
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Image /page/8/Picture/4 description: The image shows the logo for DentsCare LTDA. The logo consists of a stylized letter D with three horizontal lines inside it, followed by the text "DentsCare". To the right of the logo is the text "DENTSCARE LTDA AV. EDGAR NELSON SANTA CATARINA 8 Ph: 55 - 47 - 3441-".
AV. EDGAR NELSON MEISTER, 474, JOINVILLE,
SANTA CATARINA 89219-501 BRAZIL Ph: 55 - 47 - 3441-6131
| Applicable
Standards | ISO 29022; ISO
10993. | ISO 29022; ISO
10993. | ISO 29022; ISO
10993. | ISO 29022; ISO
10993. |
|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Composition | MDP,
methacrylate
monomers,
photo initiators,
co-initiators,
stabilizers,
Inert Load
(Silica
particles) and
Vehicle
(ethanol).
*Only in Ambar
Universal APS:
water and
surfactant. | Dimethacrylatere
sins, HEMA,
ethanol, water,
photoinitiator
system and filler. | MDP,
Dimethacrylate
resins, HEMA,
ethanol, water,
photoinitiator
system, filler
and silane. | Methacrylates,
Water,
Ethanol,
Highly
dispersed
silicon dioxide,
Initiators and
Stabilisers. |
| Device
Sterilization | Not Applicable | Not Applicable | Not Applicable | Not Applicable |
| Indication of
Use | - All classes of
direct
restoration with
composites
(class I, II, III,
IV and V);
- Adhesive
luting (in
addition to
resin cement)
of prosthetic
pieces
(post/cores,
crowns,
onlays/inlays,
veneers etc.)
made of
fiberglass,
ceromer,
ceramic, resin
and metal; | 3M™ ESPE™
Adper™ Single
Bond 2 Adhesive
is indicated for
use in the
following types
of restorations. - Direct light-
cured
composite/comp
omer
restorations - Root surface
desensitization
-Porcelain /
composite repair - Porcelain
veneers (when
used with
RelyX™ Veneer | - All classes of
fillings
(according to
Black) with
light-curing
composite or
compomer
filling materials - Cementation
of indirect
restorations
(inlays, onlays,
crowns,
bridges,
veneers) of
composite,
compomer,
ceramic, and
metal when
combined with
Suglue-10
Adhesive Resin
Cement, | - Direct-
placed light-
curing
composite and
compomer
restorations. - Direct-
placed core
build-ups with
light-, self-
and dual-
curing
composites. - Repair of
fractured
composite and
compomer
restorations. - Adhesive
cementation
of indirect
restorations |
| ceramic and
composites. | - Crown &
bridge,
inlay/onlay,
bonding
amalgam (when
used with
RelyX™ ARC
Adhesive Resin
Cement) | - Cementation
of veneers
when combined
with RelyX
Veneer
Cement,
manufactured
by 3M ESPE - Bonding of
core build-ups
made of light-
curing
composite or
core build-up
materials - Bonding of
dual-cure
cements and
core build-up
materials and
self-cure
composites
when combined
with Activator
EXL 760 - Repair of
composite or
compomer
fillings - Intraoral
repair of
composite
restorations,
porcelain fused
to metal, and
all-ceramic
restorations
without extra
primer - Root surface
desensitization - Sealing of
cavities prior to
cementation of
amalgamate
restorations - Sealing of
cavities and
preparation of
tooth stumps
prior to
temporary | with light- and
dual-curing
luting
composites. - Sealing of
prepared
tooth surfaces
before
temporary /
permanent
cementation
of indirect
restorations.
Desensitizatio
n of
hypersensitive
cervical areas. | |
| *Only for
Ambar
Universal APS:
Use as metallic
or ceramic
primer. | | | | |
| | | | cementation of
indirect
restorations
- Bonding of
fissure sealants - Protective
varnish for
glass ionomer
fillings - Surface
treatment of
porcelain,
ceramics
(including glass
ceramics,
zirconia and
alumina),
metal and
composite. | |
| How the
device
achieves its
intended
purpose | Adhesive
Material is a
light-curing,
single-
component
dental adhesive
for direct and
indirect
bonding
procedures and
etching
techniques.
With total etch
adhesives the
mineral phase
of enamel and
dentin is
superficially
demineralized
by an acidic
agent (if
necessary) in a
separate step
prior to
application of
the adhesive.
The acid used
is typically | Adhesive
Material is a
light-curing,
single-
component
dental adhesive
for direct and
indirect bonding
procedures and
etching
techniques.
With total etch
adhesives the
mineral phase of
enamel and
dentin is
superficially
demineralized by
an acidic agent
(if necessary) in
a separate step
prior to
application of the
adhesive. The
acid used is
typically
phosphoric acid
35-37%. | Adhesive
Material is a
light-curing,
single-
component
dental adhesive
for direct and
indirect
bonding
procedures and
etching
techniques.
With total etch
adhesives the
mineral phase
of enamel and
dentin is
superficially
demineralized
by an acidic
agent (if
necessary) in a
separate step
prior to
application of
the adhesive.
The acid used
is typically | Adhesive
Material is a
light-curing,
single-
component
dental
adhesive for
direct and
indirect
bonding
procedures
and etching
techniques.
With total etch
adhesives the
mineral phase
of enamel and
dentin is
superficially
demineralized
by an acidic
agent (if
necessary) in
a separate
step prior to
application of
the adhesive.
The acid used
is typically |
| | phosphoric acid
35-37%. | phosphoric acid
35-37%. | phosphoric acid
35-37%. | phosphoric acid 35-37%. |
| Side effects: | The adhesive
can cause
sensitization
reactions in
patients who
are sensitive to
any
components of
the formula. In
this case, the
material should
not be used. | The adhesive can
cause
sensitization
reactions in
patients who are
sensitive to any
components of
the formula. In
this case, the
material should
not be used. | The adhesive
can cause
sensitization
reactions in
patients who
are sensitive to
any
components of
the formula. In
this case, the
material should
not be used. | The adhesive
can cause
sensitization
reactions in
patients who
are sensitive
to any
components of
the formula.
In this case,
the material
should not be
used. |
| Primary
Package
Container: | Vial | Unit dose or vial | Unit dose or
vial | VivaPen® and
Vial |
| Shelf life | Up to 3 years | Up to 3 years | 2 years | Not found |
| Claims on
product
performance
and safety | Is a light-curing
adhesive for
bonding
restorative
materials to
dental tissue
(enamel and/or
dentin). | Is a light-curing
adhesive for
bonding
restorative
materials to
dental tissue
(enamel and/or
dentin). | Is a light-
curing adhesive
for bonding
restorative
materials to
dental tissue
(enamel and/or
dentin). | Is a light-
curing
adhesive for
bonding
restorative
materials to
dental tissue
(enamel
and/or
dentin). |
| Use the same
materials or
substances in
contact with
the same
human
tissues
or body
fluids? | YES | YES | YES | YES |
| Is the
product in
compliance to
EN ISO
10993? | YES | YES | YES | YES |
9
Image /page/9/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter "D" in a muted blue-gray color. Three horizontal wavy lines are placed within the upper part of the "D", suggesting movement or flow. Below the "D", the word "DentsCare" is written in a simple, sans-serif font, also in the same muted blue-gray color.
DENTSCARE LTDA
AV. EDGAR NELSON MEISTER, 474, JOINVILLE,
SANTA CATARINA 89219-501 BRAZIL DentsCare ph: 55 - 47 - 3441-6131
10
Image /page/10/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter "D" in a gray color. Three horizontal lines are placed inside the "D" to the left. The text "DentsCare" is written below the "D" in a sans-serif font.
DENTSCARE LTDA AV. EDGAR NELSON MEISTER, 474, JOINVILLE,
SANTA CATARINA 89219-501 BRAZIL Ph: 55 - 47 - 3441-6131
11
Image /page/11/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter 'D' in gray, with three horizontal lines emanating from the left side of the 'D', resembling sound waves or air currents. Below the 'D' is the text 'DentsCare' in a sans-serif font, also in gray. The overall design is clean and modern.
DENTSCARE LTDA
AV. EDGAR NELSON MEISTER, 474, JOINVILLE,
SANTA CATARINA 89219-501 BRAZIL DentsCare Ph: 55 - 47 - 3441-6131
12
Image /page/12/Picture/0 description: The image contains the logo and contact information for DentsCare LTDA. The logo features a stylized letter 'D' with three horizontal lines inside it, along with the name 'DentsCare' written below. The contact information includes the company's address on AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL, and their phone number: 55-47-3441-6131.
| Tissues | Enamel and
Dentin | Enamel and
Dentin | Enamel and
Dentin | Enamel and
Dentin |
|-------------------------------------------------------------------------------------|----------------------|----------------------|----------------------|----------------------|
| Reusable | NO | NO | NO | NO |
| Duration | Permanent | Permanent | Permanent | Permanent |
| Part of body | Oral, tooth | Oral, tooth | Oral, tooth | Oral, tooth |
| Is it used for
the same
clinical
condition? | YES | YES | YES | YES |
| Is it used at
the same site
in the body? | YES | YES | YES | YES |
| Is it used in a
similar
population? | YES | YES | YES | YES |
| Is it used for
the same
intended
purpose? | YES | YES | YES | YES |
| Is not
foreseen to
deliver
significantly
different
performances
? | NO | NO | NO | NO |
| Is it similar
conditions of
use? | YES | YES | YES | YES |
| Is it similar
specifications
and
properties | YES | YES | YES | YES |
| Is it similar
principles of
operation? | YES | YES | YES | YES |
13
Image /page/13/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter "D" with horizontal lines inside it, above the word "DentsCare" in a stylized font. To the right of the logo is the text "DENTSCARE AV. E SANTA Ph: 5".
DENTSCARE LTDA AV. EDGAR NELSON MEISTER, 474, JOINVILLE, A CATARINA 89219-501 BRAZIL Ph: 55 - 47 - 3441-6131
| Adhesive
Strength
(MPa) | Ambar APS
38,61 ± 1,68
Ambar
Universal APS
38,02 ± 3,33 | 26,20 ± 2,19 | 34,47 ± 3,34 | 33,27 ± 3,91 |
|---------------------------------|-----------------------------------------------------------------------|---------------|---------------|---------------|
| Conversion
rate | Ambar APS
53,8 ± 0,5
Ambar
Universal APS
55,80 ± 0,5 | 43,5 ± 1,3 | 55,60 ± 0,5 | 45,07 ± 0,6 |
| Shear bond
strength
(MPa) | Ambar APS
22,21 ± 2,33
Ambar
Universal APS
16,30 ± 1,67 | 20,06 ± 2,52 | 16,97 ± 1,83 | 11,91 ± 1,39 |
| pH | Ambar APS
3,16 ± 0,02
Ambar
Universal APS
2,97 ± 0,04 | 4,69 ± 0,03 | 3,28 ± 0,19 | Not performed |
| Viscosity
(mPa.s) | Ambar APS
81,33 ± 2,05
Ambar
Universal APS
99,20 ± 0,40 | Not performed | Not performed | Not performed |
| Water
sorption
(µg/mm³) | Ambar APS
140,80 ± 1,60
Ambar
Universal APS
145,53 ± 3,12 | 150,76 ± 2,26 | 148,38 ± 2,28 | Not performed |
| Water
solubility
(µg/mm³) | Ambar APS
64,61 ± 1,86
Ambar
Universal APS
64,71 ± 1,59 | 63,29 ± 2,59 | 71,24 ± 5,54 | Not performed |
Discussion:
The subject device is similar to the predicate devices in that they are all dental adhesives for promoting union between tooth structure (enamel and dentin) and restorative materials.
Despite differences in results, the subject device demonstrates substantial equivalence to the declared predicates, since all products meet ISO 29022 and the results match
14
Image /page/14/Picture/0 description: The image shows the logo and contact information for DentsCare LTDA. The logo features a stylized letter 'D' with three horizontal lines inside. The text includes the company name, address (AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL), and phone number (Ph: 55 - 47 - 3441-6131).
the requirements of this International Standard and it does not affect the substantial equivalence.
- Adhesive Strength: The average of the results of the adhesive under analysis is ≥ the average of the internationally renowned brand analyzed in this study.
The bond tensile strength exhibits slightly higher values than shear bond strength. Although there is no minimum tensile bond strength value, 20 MPa or more has been proposed as a reasonable value and a goal to be achieved.
By the results obtained, all the adhesives analyzed presented satisfactory results, with slightly higher values obtained by Dentscare adhesives.
The performance of Ambar APS and Ambar Universal APS satisfactorily met the requirements to support substantial equivalence to the predicate.
- Conversion rate: The average of the results of the adhesive under analysis is > the average of the internationally renowned brand analyzed in this study.
The dental compounds basically consist of a mixture of monomers, filler particles, photoinitiator system, inhibitors and dyes. The monomers have methacrylic groups with the carbon double bond, which are photoactivated, form along several polymer chains. The amount of monomers which are converted into polymers represent the major part of the final product, having a lower volume and a smaller amount of free monomers which can be leachable. An analysis of the volume of data is done by analyzing the amount of duplications that have been disrupted, indicating an expression of polymer chains. The higher the conversation rate values, better the results and efficacy of the final product.
By the results obtained, Ambar APS and Ambar Universal APS have presented the highest values, obtaining a higher efficiency of the final product when compared to the predicate. Thus, the results support substantial equivalence to the predicate.
- Shear bond strength: The average of the results of the adhesive under analysis is ≥ the average of the internationally renowned brands analyzed in this study.
The evaluation of the bonding efficiency between an adhesive and the dentin region is usually analyzed by bond strength between bonded specimens in shear or traction until fracture occurs. There is a wide variability of values (deviation) related to several factors such as water content in the dentin, cleaning of the "Smear Layer", orientation of the dentinal tubules.
The enamel structure has a high content of inorganic material (mineral hydroxyapatite) and low amount of organic material such as collagen, thus presenting a lower water content and facilitating adhesive bonding. However in dentine the amount of organic material is higher and, therefore, the humidity is also higher. As the restorative material is hydrophobic and the dentin is hydrophilic, the adhesive system has to be such that it can match both materials, thus, it must have an amphiphilic characteristic.
In summary, the higher the shear bond values, generally for bonding to the enamel, and bonding by traction, generally for adhesion to the dentin structure, the greater the effectiveness of the adhesive system.
15
Image /page/15/Picture/0 description: The image contains the logo and contact information for DentsCare LTDA. The logo features a stylized letter D with wave-like lines inside. The contact information includes the address: AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL, and the phone number: Ph: 55 - 47 - 3441-6131.
The shear bond strength is one of the indicative of adhesive performance, indicating the shear strength between the tooth / adhesive / restorative interface. In enamel indicates the union effectiveness of an orthodontic cement, for example.
The higher the shear strength or tensile strength values, the greater the effectiveness of the product.
- pH: The pH test is not contemplated in standards for adhesives, however, it is known that 7th generation adhesives must have low hydrogen potential, thus performing the role of acid conditioning.
The average of the results for pH of the adhesive under analysis demonstrate that the subject devices have lower hydrogen potential than the average of the internationally renowned brands analyzed in this study.
-
Viscosity: The viscosity property is not contemplated in regulations for adhesives. This aspect does not have impact the in the performance of the product. For this reason, the predicate devices do not refer to viscosity of the product as a quality aspect.
-
Water sorption and Water solubility: The results show that the subject devices presented Sorption and Solubility similar to the competing adhesives under analysis. There is no specific standard for sorption and solubility testing on adhesives, so we follow the testing methodology established in ISO 4049 and as an approval criterion we define that the results of our adhesives should be better or statistically equal to competitors of recognized quality on market. ISO 4049 reference values have not been taken into account, assuming that the adhesive class is not covered by this standard.
Conclusion: From the results obtained, the subject devices, Ambar APS and Ambar Universal APS demonstrate equivalent indications for use, shelf life, physical, technical and mechanical properties.
16
Image /page/16/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter "D" in a dark gray color. Inside the "D", there are three horizontal lines that resemble waves. Below the symbol, the word "DentsCare" is written in a sans-serif font, also in dark gray.
R NELSON MEISTER, 474, JOINVILLE, ARINA 89219-501 BRAZIL 47 - 3441-6131
L) Applicable Standards:
In order to meet international requirements the device Ambar APS and Ambar Universal APS was developed, as well produced in compliance with recognized international requlations and standards for the medical device industry.
ISO 29022 - Dentistry - Adhesion - Notched edge shear bond strength test
ISO 10993-1 - Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (ENISO 10993-1:2009)
ISO 10993-3 - Biological Evaluation of Medical Devices - Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity.
ISO 10993-5 - Biological Evaluation of Medical Devices - Tests for In vitro Cytotoxicity. ISO 10993-10 - Biological Evaluation of Medical Device – Tests for Irritation and Skin Sensitization.
ISO 10993-11 - Biological Evaluation of Medical Devices - Tests for Systemic Toxicity.
Conclusion:
Based on compliance with the international standard and regulation mentioned above, the device Ambar APS and Ambar Universal APS demonstrate substantial equivalence to the predicates.
17
Image /page/17/Picture/0 description: The image shows the logo for DentsCare. The logo consists of a stylized letter D with three horizontal lines inside it, followed by the text "DentsCare". To the right of the logo is the text "AV. EDGAR", "SANTA CAT", and "Ph: 55 - 47".
DENTSCARE LTDA AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL Ph: 55 - 47 - 3441-6131
M) Non-clinical Testing:
In order to study the performance of the product, pre-clinical tests were performed according to the table below, for details about test results please see attachment 01.
| Test | Specification | Results |
|---|---|---|
| Adhesive Strength | ||
| Testing on Dental | ||
| Tissue. | A comparative analysis will be carried out | |
| between commercial adhesives of | ||
| internationally recognized quality and the | ||
| adhesive under analysis. It is defined that | ||
| the acceptance criterion for this test, if the | ||
| adhesive under study has a mean $\ge$ than the | ||
| competing adhesives analyzed. | The average of the results of the adhesive | |
| under analysis is $\ge$ the average of the | ||
| internationally renowned brands analysed in this | ||
| study. | ||
| Ambar APS: 38,61 ± 1,68 (MPa) | ||
| Ambar Universal APS: 38,02 ± 3,33 (MPa) | ||
| Single Bond 2 (3M - Espe): 26,20 ± 2,19 (MPa) | ||
| Single Bond Universal: 34,47 ± 3,34 (MPa) | ||
| Tetric - N - Bond Universal: 33,27 ± 3,91 | ||
| (MPa) | ||
| Test for determining | ||
| the degree of | ||
| conversion (gc) | A comparative analysis will be carried out | |
| between commercial adhesives of | ||
| internationally recognized quality and the | ||
| adhesive under analysis. It is defined that | ||
| the acceptance criterion for this test is if the | ||
| adhesive under study has a mean $\ge$ than | ||
| the competing adhesives analyzed. | The average of the results of the adhesive | |
| under analysis is $\ge$ the average of the | ||
| internationally renowned brands analysed in this | ||
| study. | ||
| Ambar APS: 53,8 ± 0,5 | ||
| Ambar Universal APS: 55,80 ± 0,5 | ||
| Single Bond 2 (3M - Espe): 43,5 ± 1,3 | ||
| Single Bond Universal: 55,60 ± 0,5 | ||
| Tetric - N - Bond Universal: 45,07 ± 0,6 | ||
| Test of Shear bond | ||
| strength (ISO 29022: |
-
| The ISO 29022: 2013 standard does not
quantify acceptable and non-acceptable
values, so a comparative analysis will be
carried out between internationally
recognized quality commercial adhesives
and the adhesive under analysis. It is
defined that the acceptance criterion for this
test, if the adhesive under study has a mean
$\ge$ than the competing adhesives analyzed. | The average of the results of the adhesive
under analysis is $\ge$ the average of the
internationally renowned brands analysed in this
study.
Ambar APS: 22,21 ± 2,33 (MPa)
Ambar Universal APS: 16,30 ± 1,67 (MPa)
Single Bond 2 (3M - Espe): 20,06 ± 2,52 (MPa)
Single Bond Universal: 16,97 ± 1,83 (MPa)
Tetric - N - Bond Universal: 11,91 ± 1,39
(MPa) |
| pH | A comparative analysis will be carried out
between commercial adhesives of
internationally recognized quality and the
adhesive under analysis. It is defined that
the acceptance criterion for this test, if the
adhesive has low hydrogen potential as
competing adhesives analyzed. | The average of the results for pH of the
adhesive under analysis demonstrate that the
subject devices have lower hydrogen potential
than the average of the internationally
renowned brands analyzed in this study.
Ambar APS: 3,16 ± 0,02
Ambar Universal APS: 2,97 ± 0,04
Single Bond 2 (3M - Espe): 4,69 ± 0,03
Single Bond Universal (3M - Espe):
3,28 ± 0,19 |
| Viscosity | Test conducted to attend the FDA
requirement, it is no contemplated in
regulations for adhesives. However, they
have been on the market since 03/2017
(Ambar APS) and 12/2017 (Ambar Universal
APS) with no claims regarding viscosity or
stickiness, therefore, we can state that its
viscosity is in accordance with the desired
application. | Ambar APS: 81,33 ± 2,05 mPa.s
Ambar Universal APS: 99,20 ± 0,40 mPa.s |
| Water sorption | There is no specific standard for sorption
and solubility testing on adhesives, so we
follow the testing methodology established
in ISO 4049 and as an approval criterion we | The results show that the subject devices
presented Sorption and Solubility similar to the
competing adhesives under analysis.
Ambar APS: 140,80 ± 1,60 µg/mm3 |
| | define that the results of our adhesives
should be better or statistically equal to
competitors of recognized quality on
market. | Ambar Universal APS: $145,53 ± 3,12$ µg/mm³
Single Bond 2 (3M - Espe): $150,76 ± 2,26$ µg/mm³
Single Bond Universal: $148,38 ± 2,28$ µg/mm³ |
| Water solubility | There is no specific standard for sorption
and solubility testing on adhesives, so we
follow the testing methodology established
in ISO 4049 and as an approval criterion we
define that the results of our adhesives
should be better or statistically equal to
competitors of recognized quality on
market. | The results show that the subject devices
presented Sorption and Solubility similar to the
competing adhesives under analysis.
Ambar APS: $64,61 ± 1,86$ µg/mm³
Ambar Universal APS: $64,71 ± 1,59$ µg/mm³
Single Bond 2 (3M - Espe): $63,29 ± 2,59$ µg/mm3
Single Bond Universal: $71,24 ± 5,54$ µg/mm3 |
| Accelerated Stability
Studies | Study created to accelerate the possible
chemical degradation and/or physical
changes of the product in forced conditions
of storage. | Ambar APS: Considering the results observed
at the end of the 477 days of aging test, it is
concluded that the product can have its shelf
life estimated at 3 years in the storage
condition of 30° C.
Ambar Universal APS: Considering the results
observed at the end of the 225 days of aging
test, it is concluded that the product can have
its shelf life estimated at 2 years in the storage
condition of 25° C. |
| Evaluation Report of
Long-Term Stability
(Shelf) | Study designed to verify the physical and
chemical characteristics of the product
during the expected shelf life. The results
are used to confirm the expiration date and
storage conditions. | Ambar APS: Considering the results observed
at the end of the 36 months of the long-term
test (shelf), the shelf life of 3 years in the
storage condition of 30°C for the product can
be confirmed.
Ambar Universal APS: Considering the results
observed at the end of the 24 months of the
long-term test (shelf), the shelf life of 2 years
in the storage condition of 30°C for the product
can be confirmed. |
| Transport Evaluation | Study designed to verify the physical and
chemical characteristics of the product
during transport. | According to Norm ND7000046 (determination
of expiry date and storage conditions of
products), the product can be transported at
temperatures between 50°C and -5°C. |
18
Image /page/18/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter "D" in a gray color. Inside the "D", there are three horizontal wavy lines, also in gray. Below the symbol is the text "DentsCare" in a sans-serif font, also in gray.