(436 days)
No
The device description and performance studies focus on the physical and chemical properties of glass ionomer cements, with no mention of AI or ML.
No.
The device descriptions and intended uses indicate it is a dental material used for restorations, fillings, luting, and conditioning, not for treating a disease or condition therapeutically.
No
The provided text describes various glass ionomer cements and a dentin conditioner used for dental restorations, luting, and conditioning. These are materials used for treatment (restoration, bonding) and preparation for treatment, not for identifying or assessing the presence or absence of a disease or condition.
No
The device description clearly indicates the device is a physical material (glass ionomer cement and polyacrylic acid solution) used for dental restorations and cementation, not software.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use/Indications for Use: The intended uses are all related to dental procedures performed directly on a patient's teeth (restoration, core buildup, base/liner, temporary fillings, cementation, dentin pre-treatment). IVDs are used to examine specimens (like blood, urine, or tissue) taken from the body to provide information about a person's health.
- Device Description: The devices are described as dental cements and conditioners, materials used in dental procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's health status based on laboratory testing.
These devices are clearly intended for use in vivo (within the body) for dental treatment, not in vitro (in a lab) for diagnostic purposes.
N/A
Intended Use / Indications for Use
Micron Bioactive Class III and V. Restoration of cervical erosions and root surface caries, Core buildup. Base/Liner Class I, limited Class II, temporary fillings Restoration of primary teeth
Micron Superior Shades A1. A2. A3 Class III, Class V, limited Class I Restoration of primary teeth, Core buildup
Micron Superior Capsules Shades A1, A2, A3 Class III, Class V, limited Class I Restoration of primary teeth, Core buildup
Micron Luting
Base/Liner
Cementation of all types of metal, porcelain fused to metal, and resin crowns, inlays, and bridges Cementation of orthodontic bands Cementation of stainless steel crowns or orthodontic appliances retained with stainless steel crowns
Micron Dentin Conditioner Dentin pre-treatment prior to filling with glass ionomer cement
Product codes (comma separated list FDA assigned to the subject device)
EMA
Device Description
Micron Bioactive is a radiopaque, hydroxyapatite modified-glass ionomer cement.
Micron Superior is a radiopaque glass ionomer cement. It comes in shades A1, A2 and A3.
Micron Superior Capsules is a radiopaque glass ionomer cement. Capsules come in shades A1, A2 and A3.
Micron Luting is a radiopaque, self-curing translucent, particle glass-ionomer luting material.
Micron Dentin Conditioner is a mild polyacrylic acid solution designed to remove the dentinal smear layer and to condition dentine, thus enhancing the bond between glass ionomer cement and the dentine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Micron line products were tested for appearance of powder and liquid, opacity, acidsoluble lead content, setting time, compressive strength, and film thickness according to protocols based on ISO 9917-1 as was appropriate for each material. pH was tested for Micron Dentin Conditioner.
Shelf life testing was completed on all devices using relevant protocols also used for the physical characteristics tested.
All tests results met the criteria in Table 1 of ISO 9917-1.
The dental cements contain ingredients found in the predicate and reference devices so no biocompatibility testing was done.
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.
K131068, K872984, K040393, K031467
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
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
May 13, 2021
Prevest Denpro Limited % Angela Blackwell Senior Consultant Blackwell Device Consulting P.O. Box 718 Gresham, Oregon 97030
Re: K200555
Trade/Device Name: Prevest Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA Dated: February 2, 2021 Received: February 12, 2021
Dear Angela Blackwell:
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
1
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 531-542 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 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,
For Michael Adjodha 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
2
Indications for Use
510(k) Number (if known) K200555
Device Name
Prevest Dental Cements (Micron Bioactive, Micron Superior Capsules, Micron Luting and Micron Dentin Conditioner)
Indications for Use (Describe)
Micron Bioactive Class III and V. Restoration of cervical erosions and root surface caries, Core buildup. Base/Liner Class I, limited Class II, temporary fillings Restoration of primary teeth
Micron Superior Shades A1. A2. A3 Class III, Class V, limited Class I Restoration of primary teeth, Core buildup
Micron Superior Capsules Shades A1, A2, A3 Class III, Class V, limited Class I Restoration of primary teeth, Core buildup
Micron Luting
Base/Liner
Cementation of all types of metal, porcelain fused to metal, and resin crowns, inlays, and bridges Cementation of orthodontic bands Cementation of stainless steel crowns or orthodontic appliances retained with stainless steel crowns
Micron Dentin Conditioner Dentin pre-treatment prior to filling with glass ionomer cement
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
Prevest DenPro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting and Micron Dentin Conditoner) 510K Summary K200555 May 10, 2021
Name and Address: Prevest Denpro Limited Export Promotion Industrial Park Bari Brahmana, Jammu 181133 India Contact Person: Atul Modi Email: prevestindia@gmail.com Telephone: (941) 919 4280
Name of device: Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, and Micron Dentin Conditioner) Classification Name: dental cement CFR: 21 CFR 872.3275 Primary Product Code: EMA
Submission Contact:
Angela Blackwell Blackwell Device Consulting P.O. Box 718 Gresham, OR 97030-0172 (704)450-9934 angela@blackwelldevice.com
Device Description:
Micron Bioactive is a radiopaque, hydroxyapatite modified-glass ionomer cement.
Micron Superior is a radiopaque glass ionomer cement. It comes in shades A1, A2 and A3.
Micron Superior Capsules is a radiopaque glass ionomer cement. Capsules come in shades A1, A2 and A3.
Micron Luting is a radiopaque, self-curing translucent, particle glass-ionomer luting material.
Micron Dentin Conditioner is a mild polyacrylic acid solution designed to remove the dentinal smear layer and to condition dentine, thus enhancing the bond between glass ionomer cement and the dentine.
4
Indications for Use:
| Device Name | Indications |
|---|---|
| Micron Bioactive | Class III and V, |
| Restoration of cervical erosions and root surface | |
| caries, | |
| Core buildup, | |
| Base/Liner | |
| Class I, limited Class II, temporary fillings | |
| Restoration of primary teeth | |
| Micron Superior | Class III, Class V, limited Class I |
| Restoration of primary teeth, | |
| Core buildup | |
| Micron Superior Capsules | Class III, Class V, limited Class I |
| Restoration of primary teeth, | |
| Core buildup | |
| Micron Luting | Cementation of all types of metal, porcelain |
| fused to metal, and resin crowns, inlays, onlays, | |
| and bridges | |
| Cementation of orthodontic bands | |
| Cementation of stainless steel crowns or | |
| orthodontic appliances retained with stainless | |
| steel crowns | |
| Base/Liner | |
| Micron Dentin Conditioner | Dentin pre-treatment prior to filling with glass |
| ionomer cement |
Testing Summary:
Micron line products were tested for appearance of powder and liquid, opacity, acidsoluble lead content, setting time, compressive strength, and film thickness according to protocols based on ISO 9917-1 as was appropriate for each material. pH was tested for Micron Dentin Conditioner.
Shelf life testing was completed on all devices using relevant protocols also used for the physical characteristics tested.
All tests results met the criteria in Table 1 of ISO 9917-1.
The dental cements contain ingredients found in the predicate and reference devices so no biocompatibility testing was done.
Primary Predicate Device: ProGlass Cements K101869 from Silmet
5
Reference Devices: Teethmate K131068 from Kuraray Ketac Conditioner K872984 from ESPE GMBH Riva Luting Capsules K040393 from Southern Dental Industries GlasIonomer FX-2 K031467 from Shofu
Substantial Equivalence:
The acid-base cements have similar ingredients to the predicate and reference devices, the same indications for use, and similar physical parameter testing protocols based on ISO 9917-1. Shelf life testing was also similar to the predicate device shelf life testing.
| Subject Device | Predicate Device | Reference Device for additional indications | Reference Device for Hydroxyapatite ingredient | Reference Device for Ingredients | |
|---|---|---|---|---|---|
| Name | Micron Bioactive | ProGlass Two | |||
| K101869 | ProGlass Silver | ||||
| K101869 | Teethmate | ||||
| K131068 | Glaslonomer FX-2 | ||||
| K031467 | |||||
| Indications for Use | Class III and V, Restoration of cervical erosions and root surface caries, Core buildup, Base/Liner Class I, limited Class II, temporary fillings Restoration of primary teeth | Class III and V, Restoration of cervical erosions and root surface caries, Core buildup, Base/Liner | Class I, limited Class II, temporary fillings Restoration of primary teeth, Core buildup, Base/Liner | TEETHMATE DESENSITIZER is indicated for reduction of tooth hypersensitivity by the following treatments: [ 1 ] Treatment of dentin exposed by toothbrush abrasion, gingival recession, periodontal disease and/or acid erosion [2] Treatment of dentin after mechanical tooth cleaning, scaling and/or root planing [3] Treatment of tooth surface before and/ or after bleaching | Glasionomer FX-II is a glass polyalkenoate cement used for dental restorations Glasionomer FX-II is intended for use as a final restorative for deciduous teeth; a geriatric restorative for Class I, II, III and V cavities and cervical erosions; a final restorative for Class I and II of adult dentition in non-load bearing situations; an intermediate restorative for heavy stress cavities; a core build up; and for pit and fissure fillings. |
Dental Cements from Prevest Denpro Micron Line
6
| | | | | [4] Treatment
of prepared
dentin for
fillings and/or
prosthetic
restorations | |
|--------------|---------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Composition | Powder
Fluoroaluminosilicate
glass powder and
hydroxyapatite
powder
Liquid
Polyacrylic acid
solution | Powder
Alumino-
silicate
glass and
silver
Liquid
Polyacrylic
acid | Powder
Alumino-
silicate
glass and
silver
Liquid
Polyacrylic
acid | Hydroxyapatite | Powder:
Fluoroaluminosilicate
glass, pigments and
fluorescent material
Liquid: Acrylic acid
tri-carboxylic acid co-
polymer solution,
tartaric acid
Cocoa butter: Cocoa
butter, white
vaseline |
| Setting Time | 1:30 – 2 min | 3:10 min | 4 min | N/A | 2:30 min |
| | Subject Device | Predicate Device | Reference Device for
Ingredients |
|---------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Micron Superior | ProGlass Two
K101869 | Glasionomer FX-2
K031467 |
| Indications for Use | Class III, Class V, limited
Class I
Restoration of primary
teeth,
Core buildup | Class III, Class V,
limited Class I
Restoration of
primary teeth,
Core buildup | Glasionomer FX-II is
a glass polyalkenoate
cement used for
dental restorations
Glasionomer FX-II is
intended for use as a
final restorative for
deciduous teeth;
a geriatric restorative
for Class I, II, III and
V cavities and
cervical erosions; a
final restorative for
Class I and II of
adult dentition in
non-load bearing
situations; an
intermediate
restorative for heavy
stress cavities; a core
build up; |
7
| | | | and for pit and
fissure fillings. |
|--------------|-------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Composition | Powder
Fluoroaluminosilicate
glass powder
Liquid
Polyacrylic acid | Powder
Alumino-silicate
glass and polyacrylic
acid
Liquid
Polyacrylic acid and
distilled water | Powder:
Fluoroaluminosilicate
glass, pigments and
fluorescent material
Liquid: Acrylic acid
tri-carboxylic acid co-
polymer solution,
tartaric acid
Cocoa butter: Cocoa
butter, white
vaseline |
| Setting Time | A1 3:30-3:35 min
A2 5:20-5:30 min
A3 3:15-3:20 min | 3:10 min | 2:30 min |
| | Subject Device | Predicate Device | Reference Device for
Ingredients |
|---------------------|--------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Micron Superior Capsules | ProGlass Two
K101869 | Riva Luting Capsules
K040393 |
| Indications for Use | Class III, Class V, limited
Class I
Restoration of primary
teeth,
Core buildup | Class III, Class V,
limited Class I
Restoration of
primary teeth,
Core buildup | Suitable for
cementation of
crowns,
bridges, inlays and
orthodontic
bands.
Also suitable for
sealing interface
between restoration
and tooth and
base / liner in deep
restorations. |
| Composition | Powder
Fluoroaluminosilicate
glass powder
Liquid
Polyacrylic acid | Powder
Alumino-silicate
glass and polyacrylic
acid
Liquid
Polyacrylic acid and
distilled water | Powder
Fluoro Aluminosilicate
Glass
Polyacrylic Acid
Liquid
Polyacrylic acid
Tartaric Acid
water |
| Working Time | 1:30 min | 1:30-2 min | unknown |
| Setting Time | A1 3:30-3:35 min
A2 5:20-5:30 min
A3 3:15-3:20 min | 3:10 min | unknown |
8
| Subject Device | Predicate Device | Reference Device for Ingredients | |
|---|---|---|---|
| Name | Micron Luting | ProGlass One | |
| K101869 | Glaslonomer FX-2 | ||
| K031467 | |||
| Indications for Use | Cementation of all types | ||
| of metal, porcelain fused | |||
| to metal, and resin | |||
| crowns, inlays, onlays, | |||
| and bridges | |||
| Cementation of | |||
| orthodontic bands | |||
| Cementation of stainless | |||
| steel crowns or | |||
| orthodontic appliances | |||
| retained with stainless | |||
| steel crowns | |||
| Base/Liner | Cementation of all | ||
| types of metal, | |||
| porcelain fused to | |||
| metal, and resin | |||
| crowns, inlays, | |||
| onlays, and bridges | |||
| Cementation of | |||
| orthodontic bands | |||
| Cementation of | |||
| stainless steel | |||
| crowns or | |||
| orthodontic | |||
| appliances retained | |||
| with stainless steel | |||
| crowns | |||
| Base/Liner | Glasionomer FX-II is | ||
| a glass polyalkenoate | |||
| cement used for | |||
| dental restorations | |||
| Glasionomer FX-II is | |||
| intended for use as a | |||
| final restorative for | |||
| deciduous teeth; | |||
| a geriatric restorative | |||
| for Class I, 11, III and | |||
| V cavities and | |||
| cervical erosions; a | |||
| final restorative for | |||
| Class I and 11 of | |||
| adult dentition in | |||
| non-load bearing | |||
| situations; an | |||
| intermediate | |||
| restorative for heavy | |||
| stress cavities; a core | |||
| build up; | |||
| and for pit and | |||
| fissure fillings. | |||
| Composition | Powder | ||
| Fluoroaluminosilicate | |||
| glass powder | |||
| Liquid | |||
| Polyacrylic acid with thin | |||
| viscosity | Powder | ||
| Alumino-silicate | |||
| glass and polyacrylic | |||
| acid | |||
| Liquid | |||
| Polyacrylic acid and | |||
| distilled water | Powder: | ||
| Fluoroaluminosilicate | |||
| glass, pigments and | |||
| fluorescent material | |||
| Liquid: Acrylic acid | |||
| tri-carboxylic acid co- | |||
| polymer solution, | |||
| tartaric acid | |||
| Cocoa butter: Cocoa | |||
| butter, white | |||
| vaseline | |||
| Setting Time | 2:30 min | 3:10 min | 2:30 min |
| Subject Device | Predicate Device | |
|---|---|---|
| Name | Micron Dentin | |
| Conditioner | Ketac Conditioner | |
| K872984 | ||
| Indications for Use | Dentin pre-treatment | |
| prior to filling with glass | ||
| ionomer cement |
9
| Composition | Polyacrylic acid solution | Polyacrylic acid solution |
|---|---|---|
| ------------- | --------------------------- | --------------------------- |
Shelf life testing for all 5 devices is 3 years (testing for two devices was done on each of 3 shades) and used the same physical parameters protocols as the testing. This is the same type of protocols as the shelf life testing for the predicate devices from Silmet but the current shelf life of those devices is unknown.
Conclusion: Prevest Denpro Powder/Liquid Acid-Base dental cements are substantially equivalent to the predicate devices, ProGlass. They have the same indications, similar testing (including shelf life testing), and very similar ingredients. Both the subject devices and the predicate devices have setting times which meet requirements of ISO 9917-1 Table 1 for the respective type of cement. Reference devices are included to cover any ingredients, or indications not covered by the predicate devices. Any differences in ingredients are minor and do not change the substantial equivalence.