PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM

K992518 · Dentsply Intl. · EBC · Sep 22, 1999 · Dental

Device Facts

• Record ID: K992518
• Device Name: PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM
• Applicant: Dentsply Intl.
• Product Code: EBC · Dental
• Decision Date: Sep 22, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3765
• Device Class: Class 2

Intended 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 .

Device Story

Prime & Bond NT Dental Adhesive System is a one-component, no-mix, visible light-curable dental bonding agent containing fluoride. Used by dental professionals in clinical settings to facilitate adhesion of restorative materials to tooth structure. Device applied to prepared tooth surfaces prior to placement of pit and fissure sealants or other restorative materials. Light-curing initiates polymerization, creating a bond between the tooth and the restorative material. Benefits include improved retention and reduced microleakage for dental restorations. Device is unchanged from predicate K982394; submission covers new indication for use with pit and fissure sealants.

Clinical Evidence

Bench testing only. Adhesion strength (MPa) of Dyract Seal Pit & Fissure Sealant to enamel was measured at 0, 2, 4, 6, 8, and 12 months using Prime & Bond NT with NRC conditioner versus phosphoric acid (DeTrey Conditioner 36). Results showed comparable long-term adhesion (e.g., 9.4 MPa vs 10.5 MPa at 12 months). Micromorphology study confirmed good bonding properties.

Technological Characteristics

One-component, no-mix, visible light-curable resin-based dental bonding agent containing fluoride. Unchanged from K982394. No specific ASTM materials or software algorithms described.

Indications for Use

Indicated for use in conjunction with pit and fissure sealants, direct composite/compomer restorations, composite/ceramic/amalgam repairs, cavity varnish for fresh amalgam, indirect restorations (inlays, onlays, veneers, crowns, bridges), endodontic post cementation, and adhesive bonding of direct amalgam restorations.

Regulatory Classification

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.

Predicate Devices

• Prime & Bond® NT™ Universal Dental Adhesive System (K982394)

Reference Devices

• Dyract® Seal Compomer Pit & Fissure Sealant
• NRC™ Non-Rinse Conditioner
• DeTrey® Conditioner 36

Submission Summary (Full Text)

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# 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 [phone]

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.

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## 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<br>(24h) MPa |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Nupro® Prophylaxis Paste, Medium Grit; rinse; dry; NRCTM Conditioner;<br>20"; dry; DyractSealTM Pit and Fissure Sealant | $8.79 \pm 1.56$ |
| Nupro® Prophylaxis Paste, Medium Grit; rinse; dry; Etchgel Conditioner;<br>20"; rinse; dry; DyractSealTM Pit and Fissure Sealant | $12.93 \pm 1.41$ |
| Nupro® Prophylaxis Paste, Medium Grit; rinse; dry; NRCTM Conditioner;<br>20"; dry; Prime & Bond® NTTM Adhesive; 20"; DyractSealTM Pit and<br>Fissure Sealant | $11.09 \pm 2.38$ |
| Nupro® Prophylaxis Paste, Medium Grit; rinse; dry; Etchgel Conditioner;<br>20"; rinse; dry; Prime & Bond® NTTM Adhesive; 20"; DyractSealTM Pit<br>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<br>(months) | Adhesion (MPa) of Dyract® Seal Pit & Fissure Sealant to enamel using: | |
|------------------|-----------------------------------------------------------------------|---------------------------------------------------------------------|
| | DeTrey® Conditioner 36* | NRC™ Non-Rinse Conditioner and<br>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.

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## 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.

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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

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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)**