(56 days)
Not Found
No
The summary describes a dental adhesive system and its performance in adhesion tests. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No.
The device is a dental adhesive system used for bonding and repairs, which serves an auxiliary function in dental procedures rather than directly treating a disease or condition.
No
The device description, intended use, and performance data all indicate that this is a dental adhesive system used for bonding and restorative procedures, not for diagnosing medical conditions.
No
The device description clearly states it is a "one-component, no-mix visible light-curable dental bonding agent that contains fluoride," which is a physical substance, not software. The performance studies also focus on the adhesive strength of this physical material.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses listed are all related to dental procedures performed directly on the patient's teeth (bonding restorations, sealing pits and fissures, etc.). IVDs are used to examine specimens taken from the human body (blood, urine, tissue, etc.) to provide information about a person's health.
- Device Description: The description of the device as a "one-component, no-mix visible light-curable dental bonding agent" aligns with a product used in dental treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, detecting analytes, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on adhesion strength to enamel, which is a measure of the device's effectiveness in a dental application, not its ability to accurately measure or detect substances in a biological sample.
Therefore, the PRIME & BOND® NT™ DENTAL ADHESIVE SYSTEM is a dental device used for bonding and sealing teeth, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The new Indication for Use for PRIME & BOND® NT™ DENTAL ADHESIVE SYSTEM is for use in conjunction with pit and fissure sealant.
Current Indications, K982394:
- Direct composite and compomer restorations .
- Composite, ceramic and amalgam repairs .
- Cavity varnish for use with fresh amalgam .
- Indirect restorations: Dual Cure, inlays, onlays, veneers, crowns and bridges
- . Endodontic post cementation
- Adhesive bonding of direct amalgam restorations .
Product codes (comma separated list FDA assigned to the subject device)
EBC
Device Description
PRIME & BOND® NT™ DENTAL ADHESIVE SYSTEM is a onecomponent, no-mix visible light-curable dental bonding agent that contains fluoride.
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)
Performance Data:
Dyract® Seal Compomer Pit & Fissure Sealant with NRC™ Non-Rinse Conditioner pretreatment, combined with PRIME & BOND® NT™ DENTAL ADHESIVE, develops an adhesive strength to enamel that is comparable to Dyract® Seal Compomer Pit & Fissure Sealant with an acid etchant pretreatment.
| PRETREATMENT USED | ADHESION (24h) MPa |
|---|---|
| Nupro® Prophylaxis Paste, Medium Grit; rinse; dry; NRCTM Conditioner; | |
| 20"; dry; DyractSealTM Pit and Fissure Sealant | $8.79 \pm 1.56$ |
| Nupro® Prophylaxis Paste, Medium Grit; rinse; dry; Etchgel Conditioner; | |
| 20"; rinse; dry; DyractSealTM Pit and Fissure Sealant | $12.93 \pm 1.41$ |
| Nupro® Prophylaxis Paste, Medium Grit; rinse; dry; NRCTM Conditioner; | |
| 20"; dry; Prime & Bond® NTTM Adhesive; 20"; DyractSealTM Pit and | |
| Fissure Sealant | $11.09 \pm 2.38$ |
| Nupro® Prophylaxis Paste, Medium Grit; rinse; dry; Etchgel Conditioner; | |
| 20"; rinse; dry; Prime & Bond® NTTM Adhesive; 20"; DyractSealTM Pit | |
| and Fissure Sealant | $13.01 \pm 3.21$ |
The long-term adhesion of DyractSeal was tested under various pretreatments.
| Time
| (months) | Adhesion (MPa) of Dyract® Seal Pit & Fissure Sealant to enamel using: | |
|---|---|---|
| DeTrey® Conditioner 36* | NRC™ Non-Rinse Conditioner and Prime & Bond® NT™ Dental Adhesive | |
| 0 | 14.1 ± 1.8 | 12.5 ± 2.1 |
| 2 | 12.0 ± 0.64 | 9.4 ± 2.0 |
| 4 | 11.7 ± 1.0 | 11.7 ± 0.6 |
| 6 | 11.1 ± 1.8 | 11.2 ± 2.6 |
| 8 | 12.5 ± 1.8 | 10.5 ± 1.7 |
| 12 | 10.5 ± 2.2 | 9.4 ± 2.2 |
| *36% phosphoric acid gel |
In addition to the above data, a micromorphology study was also conducted; the results showed good bonding properties. The study report can be found in Exhibit A.
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.
Not Found
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
§ 872.3765 Pit and fissure sealant and conditioner.
(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(b)
Classification. Class II.
0
510(k) SUMMARY
NAME & ADDRESS:
992518
ENTSPLY International
West College Avenue ). Box 872 k. PA 17405-0872 1 845-7511 542343
P. J. Lehn Telefax (717) 849-4343
CONTACT: P. Jeffery Lehn
DATE PREPARED: "}}}} { } = 1099
TRADE OR PROPRIETARY NAME: PRIME & BOND® NT™ DENTAL ADHESIVE SYSTEM
CLASSIFICATION NAME: Resin tooth bonding agent 872.3200
PREDICATE DEVICE: Prime & Bond® NT™ Universal Dental Adhesive System K982394
DEVICE DESCRIPTION: PRIME & BOND® NT™ DENTAL ADHESIVE SYSTEM is a onecomponent, no-mix visible light-curable dental bonding agent that contains fluoride.
INTENDED USE: The new Indication for Use for PRIME & BOND® NT™ DENTAL ADHESIVE SYSTEM is for use in conjunction with pit and fissure sealant.
TECHNOLOGICAL CHARACTERISTICS: PRIME & BOND® NT™ Dental Adhesive System is unchanged from the initial submission, K982394. This premarket submission is for a new intended use only.
We believe the fact that the device is unchanged from the predicate device (K982394) and that the performance data provided,support the safety and effectiveness of PRIME & BOND® NT™ DENTAL ADHESIVE SYSTEM for the new indication for use.
000012
1
Substantial Equivalence Comparison:
Prime & Bond® NT™ Dental Adhesive System is unchanged from the initial submission, K982394. This premarket submission is for a new intended use only.
Performance Data:
Dyract® Seal Compomer Pit & Fissure Sealant with NRC™ Non-Rinse Conditioner pretreatment, combined with PRIME & BOND® NT™ DENTAL ADHESIVE, develops an adhesive strength to enamel that is comparable to Dyract® Seal Compomer Pit & Fissure Sealant with an acid etchant pretreatment.
| PRETREATMENT USED | ADHESION
(24h) MPa |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Nupro® Prophylaxis Paste, Medium Grit; rinse; dry; NRCTM Conditioner;
20"; dry; DyractSealTM Pit and Fissure Sealant | $8.79 \pm 1.56$ |
| Nupro® Prophylaxis Paste, Medium Grit; rinse; dry; Etchgel Conditioner;
20"; rinse; dry; DyractSealTM Pit and Fissure Sealant | $12.93 \pm 1.41$ |
| Nupro® Prophylaxis Paste, Medium Grit; rinse; dry; NRCTM Conditioner;
20"; dry; Prime & Bond® NTTM Adhesive; 20"; DyractSealTM Pit and
Fissure Sealant | $11.09 \pm 2.38$ |
| Nupro® Prophylaxis Paste, Medium Grit; rinse; dry; Etchgel Conditioner;
20"; rinse; dry; Prime & Bond® NTTM Adhesive; 20"; DyractSealTM Pit
and Fissure Sealant | $13.01 \pm 3.21$ |
It is essential for the clinical success of a pit and fissure sealant, that the sealant develops a durable adhesion resulting in long-term protection , e.g., against microleakage. Therefore the long-term adhesion of DyractSeal was tested under various pretreatments.
| Time
| (months) | Adhesion (MPa) of Dyract® Seal Pit & Fissure Sealant to enamel using: | |
|---|---|---|
| DeTrey® Conditioner 36* | NRC™ Non-Rinse Conditioner and | |
| Prime & Bond® NT™ Dental Adhesive | ||
| 0 | 14.1 ± 1.8 | 12.5 ± 2.1 |
| 2 | 12.0 ± 0.64 | 9.4 ± 2.0 |
| 4 | 11.7 ± 1.0 | 11.7 ± 0.6 |
| 6 | 11.1 ± 1.8 | 11.2 ± 2.6 |
| 8 | 12.5 ± 1.8 | 10.5 ± 1.7 |
| 12 | 10.5 ± 2.2 | 9.4 ± 2.2 |
*36% phosphoric acid gel
In addition to the above data, a micromorphology study was also conducted; the results showed good bonding properties. The study report can be found in Exhibit A.
2
Safety Data:
Prime & Bond® NT™ Dental Adhesive System is unchanged from the initial submission, K982394. This premarket submission is for a new intended use only.
The safety of the device has not been affected.
We believe the fact that the device is unchanged from the predicate device (K982394) and that the performance data provided,support the safety and effectiveness of PRIME & BOND® NT™ DENTAL ADHESIVE SYSTEM for the new indication for use.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract design that resembles a bird or a stylized human profile.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 2 1999
Mr. P. Jeffery Lehn Director, Corporate Compliance and Regulatory Affairs Dentsply International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872
K992518 Re :
Prime & Bond® NT™ Universal Dental Adhesive Trade Name: System Regulatory Class: II Product Code: EBC Dated: July 27, 1999 Received: July 28, 1999
Dear Mr. Lehn:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
4
Page 2 - Mr. Lehn
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4690. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Patricia Cuardeflor
Timothy A. Ulatowski Director Division of Dental, Infection Cor and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/0 description: The image shows the text "ENCLOSURE A K972518 Revised 9/14/99". The text is in black and is bolded. The text is centered in the image. The text is likely a document number or a reference number.
510(k) NUMBER (IF KNOWN): K992518
DEVICE NAME: PRIME & BOND® NT™ DENTAL ADHESIVE SYSTEM
INDICATIONS FOR USE:
Addition of New Indication: To be used in conjunction with pit and fissure sealant
Current Indications, K982394:
- Direct composite and compomer restorations .
- Composite, ceramic and amalgam repairs .
- Cavity varnish for use with fresh amalgam .
- Indirect restorations: Dual Cure, inlays, onlays, veneers, crowns and bridges
- . Endodontic post cementation
- Adhesive bonding of direct amalgam restorations .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
000007
Susan Ruan
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital C 510(k) Number
L
escription Use
(Per 21 CFR 801.109)