K Number
K160232
Device Name
Disposable Barrier Sleeves and Covers
Date Cleared
2016-06-07

(127 days)

Product Code
Regulation Number
878.4370
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Disposable Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.
Device Description
The proposed devices. Disposable Barrier Sleeves and Covers, are made of polyethylene film and are used as accessories to dental instruments and equipment used during dental procedures. These disposable barrier sleeves and covers are offered in various shapes and sizes to fit over and cover the intended dental instruments and equipment. The Disposable Barrier Sleeves slip over the ends of the respective devices, allowing for the attachment and/or protrusion (where applicable) of those parts of the devices used during dental procedures. The Disposable Barrier Cover is placed over equipment, such as dental chair head rests and trays, to cover those parts. The proposed devices, Disposable Barrier Sleeves and Covers, act as a physical barrier, augmenting existing infection control techniques, and facilitate clean-up.
More Information

Not Found

No
The device description and performance studies focus solely on the physical barrier properties and material characteristics of disposable sleeves and covers, with no mention of AI or ML.

No
The device is described as a disposable barrier for dental instruments and equipment, intended to augment infection control and facilitate cleanup, not to treat or cure any condition.

No

Explanation: The device, Disposable Barrier Sleeves and Covers, is described as a physical barrier for dental instruments and equipment to augment infection control techniques and facilitate clean-up. It does not mention any function related to diagnosing diseases or conditions.

No

The device is described as physical barrier sleeves and covers made of polyethylene film, which are hardware components, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is clearly stated as serving as a disposable barrier for dental instruments and equipment to augment infection control techniques and facilitate clean-up. This is a physical barrier function, not a diagnostic one.
  • Device Description: The description details the physical nature of the sleeves and covers and their function as a physical barrier. There is no mention of analyzing samples from the human body or providing diagnostic information.
  • Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples (blood, urine, tissue, etc.)
    • Detecting or measuring substances in biological samples
    • Providing information for the diagnosis, monitoring, or treatment of a disease or condition
    • Using reagents or assays

The device is a physical barrier used in a dental setting for infection control, which falls outside the scope of In Vitro Diagnostics.

N/A

Intended Use / Indications for Use

Disposable Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.

Product codes (comma separated list FDA assigned to the subject device)

PEM

Device Description

The proposed devices. Disposable Barrier Sleeves and Covers, are made of polyethylene film and are used as accessories to dental instruments and equipment used during dental procedures. These disposable barrier sleeves and covers are offered in various shapes and sizes to fit over and cover the intended dental instruments and equipment. The Disposable Barrier Sleeves slip over the ends of the respective devices, allowing for the attachment and/or protrusion (where applicable) of those parts of the devices used during dental procedures. The Disposable Barrier Cover is placed over equipment, such as dental chair head rests and trays, to cover those parts.

The proposed devices, Disposable Barrier Sleeves and Covers, act as a physical barrier, augmenting existing infection control techniques, and facilitate clean-up.

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)

Biocompatibility Testing:

  • In-Vitro Cytotoxicity: Pass
  • Sensitization: Pass
  • Irritation: Pass

Performance Testing:

  • Synthetic Blood Penetration: Pass
  • Synthetic Blood Penetration at seams and non-continuous components: Pass
  • Viral Penetration: Pass
  • Viral Penetration at seams and non-continuous components: Pass

Mechanical Property Testing:

  • Tensile Strength: 0.02mm Acceptable, 0.03mm Acceptable, 0.05mm Comparable to Predicate
  • Puncture Resistance: 0.02mm Acceptable, 0.03mm Acceptable, 0.05mm Comparable to Predicate
  • Tear Resistance: 0.02mm Acceptable, 0.03mm Acceptable, 0.05mm Comparable to Predicate

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.

K132953

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

§ 878.4370 Surgical drape and drape accessories.

(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 7, 2016

DENTSPLY International Ms. Helen Lewis Director Corporate Regulatory Affairs 221 West Philadelphia Street, Suite 60W York, Pennsylvania 17401

Re: K160232

Trade/Device Name: Disposable Barrier Sleeves and Covers Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: PEM Dated: May 6, 2016 Received: May 9, 2016

Dear Ms. Lewis:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

1

the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runno, DDS, MA

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control. and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K160232

Device Name Disposable Barriers Sleeves and Covers

Indications for Use (Describe)

Disposable Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.

See the attached table for the product names, trade names and model numbers.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

| | Disposa-Shield® Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instruments
and equipment. This device is non-sterile and intended for single patient use only. | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Models: | | | |
| Part Number
(SKU) | Description | Designed For | |
| A88005 | Disposable Barrier for Low Speed, Contra-Angle Handpiece | Low Speed, Contra-Angle Handpieces | |
| 65090003 | DISPOSA-SHIELD® No. 3 Air Turbines and
Cavitron, A88005 | Fits Cavitron Handpiece
Low Speed, Contra-Angle Handpieces
Fits Cavitron Handpiece | |
| A88006 | Disposable Barrier for Low Speed, Long Handpiece | Low Speed, Long Handpieces
Fits: SmartLite PS, Tulsa 6:1,
Contra Angle Handpiece by Sirona,
e³ Torque Control Motor, MIDWEST Handpiece | |
| A88007 | Disposable Barrier for Universal Air/Water Syringe | Universal Air/Water Syringe
(syringe type delivery system) | |
| 65090002 | DISPOSA-SHIELD® No. 2 Air Motors, A88007 | Universal Air/Water Syringe
(syringe type delivery system) | |
| A88008 | Disposable Barrier for Light Handle (T-Bar) | Light Handle (T-Bar) | |
| A88013 | Disposable Barrier for Standard Type Delivery
Systems | Syringe Type Delivery Systems
Fits Delton FS+ Syringe | |
| A880095 | Disposable Barrier for Dental Hose | Dental Hose | |
| A880105 | Disposable Barrier for Universal Chair/X-Ray Head | Universal Chair / X-Ray Head | |
| A880115 | Disposable Barrier for Multi-Purpose Use | Multi-Purpose Use | |
| 65090001 | DISPOSA-SHIELD® No. 1 Light Handles and Control
Panels, A880115 | Multi-Purpose Use | |
| A88014 | Disposable Barrier for Tray Size 10 ½" x 14½" | Tray Size 10-1/2" x 14-1/2" | |
| A88015 | Disposable Barrier for Tray Size 12" x 17" | Tray Size 12" x 17" | |
| A88016 | Disposable Barrier for Dental Chair Head Rest | Dental Chair Head Rest | |
| 65090004 | DISPOSA-SHIELD® No. 4 Headrest Cover, A88016 | Dental Chair Head Rest | |
| A88018 | Disposable Barrier for Midwest RDH Freedom Inner
Module | Midwest RDH Freedom Inner Module | |
| A88019 | Disposable Barrier for Midwest RDH Freedom with
SmartMode Technology Inner Module | Midwest RDH Freedom Cordless Prophy System with
SmartMode Technology | |
| Part Number (SKU) | Description | Designed For | |
| 737007 | Disposable Barrier for Standard Type Delivery Systems, Trial Pack for A88013 | Syringe Type Delivery Systems
Fits Delton FS+ Syringe | |
| 90736 | Disposable Barrier for Midwest RDH Freedom Inner Module, Trial Pack for A88018 | Midwest RDH Freedom Inner Module | |
| 978079 | Bebop Barrier Sleeve | Impression Material Dispenser | |
| RINN® Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only. | | | |
| Models:
Part Number (SKU) | Description | Designed For | |
| 050500 | Universal Digital Sensor Covers (Bulk) | RINN® Digital Sensor Covers, Size 1 and Size 2 | |
| 550500 | Universal Digital Sensor Covers | RINN® Digital Sensor Covers, Size 1 and Size 2 | |
| 550200 | Large Sensor Cover
(Soft Overbag Cover) | RINN® Large Digital Sensors
Sized to overbag sensor and sensor holder (such as Snap-A-Ray DS) | |
| 550143 | Tight Digital Sensor Cover –
Size 1.5/2, 300-pack | Digital Sensors, size 1.5/2
Fits the following size 1.5 and 2 sensors:
Schick CDR, Schick 33, Dexis, Kodak 6100, Gendex eHd, Gendex GXS-700 | |
| 055574 | Tight Digital Sensor Cover –
Size 1.5/2, 25-pack | Digital Sensors, size 1.5/2
Fits the following size 1.5 and 2 sensors:
Schick CDR, Schick 33, Dexis, Kodak 6100, Gendex eHd, Gendex GXS-700 | |
| 055629 | Tight Digital Sensor Cover –
Size 1.5/2 | Digital Sensors, size 1.5/2
Fits the following size 1.5 and 2 sensors:
Schick CDR, Schick 33, Dexis, Kodak 6100, Gendex eHd, Gendex GXS-700 | |
| 550149 | Tight Sensor Cover –
Size 1, 300-pack | Digital Sensors, size 1
Fits the following size 1 sensors:
Planmeca, Instrumentarium, Schick, Gendex, Kodak, Dentex | |
| Part Number
(SKU) | Description | Designed For | |
| 055575 | Tight Digital Sensor Cover -
Size 1, 25-pack | Digital Sensors, size 1
Fits the following size 1 sensors:
Planmeca, Instrumentarium, Schick, Gendex, Kodak,
Dentex | |
| 055630 | Tight Sensor Covers –
Size 1 | Digital Sensors, size 1
Fits the following size 1 sensors:
Planmeca, Instrumentarium, Schick, Gendex, Kodak,
Dentex | |
| | Sani-Shield® and Sani-Tip® Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental
instruments and equipment. This device is non-sterile and intended for single patient use only.
Models: 120126, 130010 and 1300105 Disposable Barrier for Air/Water Syringes air designed for Sani-Tip
air/water syringe tips. | | |
| | Smartlite® Max Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instruments
and equipment. This device is non-sterile and intended for single patient use only.
Model:
644060 SmartLite® Max Disposable Barrier Sleeves is designed for SmartLite® Max L.E.D Curing Light.
644.50.030 SmartLite Focus Sleeve Refill is designed for Caulk K-156 SL Focus, SL PS. | | |
| | Endo® Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instruments and
equipment. This device is non-sterile and intended for single patient use only.
Model: EAPB100 (EAS100) EndoActivator Protective Barrier is designed for EAD100 EndoActivator
Handpiece/Driver. | | |
| | digit® power Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instruments
and equipment. This device is non-sterile and intended for single patient use only.
Model: 678079 digit® power Disposable Barrier Sleeves Refill is designed for Aquasil Ultra cordless Tissue
Managing Impression System and Fits digit® power Dispenser. | | |

4

5

6

Dentsply Sirona 221 West Philadelphia Street Suite 60 York, PA 17404

Image /page/6/Picture/1 description: The image shows the logo for Dentsply Sirona. The logo consists of a stylized, abstract shape on the left, resembling a leaf or a curved form in gray. To the right of the shape are the words "Dentsply" on the top line and "Sirona" on the bottom line, both in a simple, sans-serif font and in the same gray color as the abstract shape. The overall design is clean and modern.

SECTION 5. 510(k) SUMMARY for Disposable Barrier Sleeves and Covers

1. Submitter Information:

Dentsply Sirona 221 West Philadelphia Street Suite 60 York, PA 17404

Contact Person:Helen Lewis
Telephone Number:717-487-1332
Fax Number:717-849-4343

Date Prepared: 29 January 2016

2. Device Name:

  • Proprietary Name: Disposable Barrier Sleeves and Covers ●
    II

  • Classification Name: Dental Barriers and Sleeves

  • CFR Number: 878.4370

  • Device Class: ●

  • . Product Code: PEM

3. Predicate Device:

.

.

Predicate Device Name510(k)Company Name
TIDIShield™ Curing
Light SleeveK132953TIDI Products, LLC

4. Description of Device:

The proposed devices. Disposable Barrier Sleeves and Covers, are made of polyethylene film and are used as accessories to dental instruments and equipment used during dental procedures. These disposable barrier sleeves and covers are offered in various shapes and sizes to fit over and cover the intended dental instruments and equipment. The Disposable Barrier Sleeves slip over the ends of the respective devices, allowing for the attachment and/or protrusion (where applicable) of those parts of the devices used during dental procedures. The Disposable Barrier Cover is placed over equipment, such as dental chair head rests and trays, to cover those parts.

The proposed devices, Disposable Barrier Sleeves and Covers, act as a physical barrier, augmenting existing infection control techniques, and facilitate clean-up.

7

5. Indications for Use:

Disposable Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.

See the attached table for the product names, trade names and model numbers.

Disposa-Shield® Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only. Models:

| Part
Number

(SKU)DescriptionDesigned For
A88005Disposable Barrier for Low Speed, Contra-Angle HandpieceLow Speed, Contra-Angle Handpieces
Fits Cavitron Handpiece
65090003DISPOSA-SHIELD® No. 3 Air Turbines and
Cavitron, A88005Low Speed, Contra-Angle Handpieces
Fits Cavitron Handpiece
A88006Disposable Barrier for Low Speed, Long
HandpieceLow Speed, Long Handpieces
Fits:
SmartLite PS
Tulsa 6:1,
ContraAngle Handpiece by Sirona
e3 Torque Control Motor
MIDWEST Handpiece
A88007Disposable Barrier for Universal Air/Water
SyringeUniversal Air/Water Syringe
(syringe type delivery system)
65090002DISPOSA-SHIELD® No. 2 Air Motors,
A88007Universal Air/Water Syringe
(syringe type delivery system)
A88008Disposable Barrier for Light Handle (T-Bar)Light Handle (T-Bar)
A88013Disposable Barrier for Standard Type Delivery
SystemsSyringe Type Delivery Systems
Fits Delton FS+ Syringe
A880095Disposable Barrier for Dental HoseDental Hose
A880105Disposable Barrier for Universal Chair/X-Ray
HeadUniversal Chair / X-Ray Head
A880115Disposable Barrier for Multi-Purpose UseMulti-Purpose Use
65090001DISPOSA-SHIELD® No. 1 Light Handles and
Control Panels, A880115Multi-Purpose Use
A88014Disposable Barrier for Tray Size 10 $^{1}!/_{2}$ " x 14
$^{1}!/_{2}$ "Tray Size 10-1/2" x 14-1/2"
Part
Number
(SKU)DescriptionDesigned For
A88015Disposable Barrier for Tray Size 12" x 17"Tray Size 12" x 17"
A88016Disposable Barrier for Dental Chair Head RestDental Chair Head Rest
65090004DISPOSA-SHIELD® No. 4 Headrest Cover,
A88016Dental Chair Head Rest
A88018Disposable Barrier for Midwest RDH Freedom
Inner ModuleMidwest RDH Freedom Inner Module
A88019Disposable Barrier for Midwest RDH Freedom
with SmartMode Technology Inner ModuleMidwest RDH Freedom Cordless
Prophy System with SmartMode
Technology Inner Module
737007Disposable Barrier for Standard Syringe Type
Delivery Systems, Trial Pack for A88013Syringe Type Delivery Systems
Fits Delton FS+ Syringe
90736Disposable Barrier for Midwest RDH Freedom
Inner Module, Trial Pack for A88018Midwest RDH Freedom Inner Module
978079Bebop Barrier SleeveImpression Material Dispenser

8

RINN® Universal Digital Sensor Covers are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.

Models:

| Part
Number

(SKU)DescriptionDesigned For
050500Universal Digital Sensor Covers (Bulk)RINN® Digital Sensor Covers, Size 1
and Size 2
550500Universal Digital Sensor CoversRINN® Digital Sensor Covers, Size 1
and Size 2
550200Large Sensor Cover
(Soft Overbag Cover)RINN® Large Digital Sensors
Sized to overbag sensor and sensor
holder (such as Snap-A-Ray DS)
Part
Number
(SKU)DescriptionDesigned For
550143Tight Digital Sensor Cover -
Size 1.5/2, 300-packDigital Sensors, size 1.5/2
Fits the following size 1.5 and 2
sensors:
Schick CDR, Schick 33, Dexis, Kodak
6100, Gendex eHd, Gendex GXS-700
055574Tight Digital Sensor Cover -
Size 1.5/2, 25-packDigital Sensors, size 1.5/2
Fits the following size 1.5 and 2
sensors:
Schick CDR, Schick 33, Dexis, Kodak
6100, Gendex eHd, Gendex GXS-700
055629Tight Digital Sensor Cover -
Size 1.5/ 2Digital Sensors, size 1.5/2
Fits the following size 1.5 and 2
sensors:
Schick CDR, Schick 33, Dexis, Kodak
6100, Gendex eHd, Gendex GXS-700
550149Tight Sensor Cover -
Size 1, 300-packDigital Sensors, size 1
Fits the following size 1 sensors:
Planmeca, Instrumentarium, Schick,
Gendex, Kodak, Dentex
055575Tight Digital Sensor Cover -
Size 1, 25-packDigital Sensors, size 1
Fits the following size 1 sensors:
Planmeca, Instrumentarium, Schick,
Gendex, Kodak, Dentex
055630Tight Sensor Covers –
Size 1Digital Sensors, size 1
Fits the following size 1 sensors:
Planmeca, Instrumentarium, Schick,
Gendex, Kodak, Dentex

9

Sani-Shield® and Sani-Tip® Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.

Models: 120126, 130010 and 1300105 Disposable Barrier for Air/Water Syringes air designed for Sani-Tip air/water syringe tips.

10

Smartlite® Max Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.

Model:

644060 SmartLite® Max Disposable Barrier Sleeves is designed for SmartLite® Max L.E.D Curing Light.

644.050.030 SmartLite Focus Sleeve Refill is designed for Caulk K-156 SL Focus, SL PS.

Endo® Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.

Model: EAPB100 (EAS100) EndoActivator Protective Barrier is designed for EAD100 EndoActivator Handpiece/Driver.

digit® power Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.

Model: 678079 digit® power Disposable Barrier Sleeves Refill is designed for Aquasil Ultra cordless Tissue Managing Impression System and Fits digit® power Dispenser.

11

6. Substantial Equivalence:

Table 5.2 Technological Characteristics

ElementProposed DevicePredicate Device
Disposable Barrier Sleeves and CoversTIDIShield™ Curing
Light Sleeve (K132953)
510(k)To be assignedK132953
Indications for
UseDisposable Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.

See the attached table for the product names, trade names and model numbers. | TIDIShield™ Curing
Light Sleeves are
indicated for use as a
barrier that is used as an
accessory to dental
instrument. These sleeves
are non-sterile and are
intended for single patient
only. |

12

| Element | Proposed Device
Disposable Barrier Sleeves and Covers | | Predicate Device |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Disposa-Shield® Barrier Sleeves and Covers are intended to serve as a disposable
barrier for dental instruments and equipment. This device is non-sterile and intended
for single patient use only.
Models: | | TIDIShield™ Curing
Light Sleeve (K132953) |
| | Part
Number
(SKU) | Description | Designed For |
| | A88005 | Disposable Barrier for Low Speed, Contra-Angle Handpiece | Low Speed, Contra-Angle Handpieces
Fits Cavitron Handpiece |
| | 65090003 | DISPOSA-SHIELD® No. 3 Air Turbines
and Cavitron, A88005 | Low Speed, Contra-Angle Handpieces
Fits Cavitron Handpiece |
| | A88006 | Disposable Barrier for Low Speed, Long
Handpiece | Low Speed, Long Handpieces
Fits: SmartLite PS,Tulsa 6:1,
ContraAngle Handpiece by Sirona,
e³ Torque Control Motor, MIDWEST
Handpiece |
| | A88007 | Disposable Barrier for Universal
Air/Water Syringe | Universal Air/Water Syringe
(syringe type delivery system) |
| | 65090002 | DISPOSA-SHIELD® No. 2 Air Motors,
A88007 | Universal Air/Water Syringe
(syringe type delivery system) |
| | A88008 | Disposable Barrier for Light Handle (T-
Bar) | Light Handle (T-Bar) |
| | A88013 | Disposable Barrier for Standard Type
Delivery Systems | Syringe Type Delivery Systems
Fits Delton FS+ Syringe |
| | A880095 | Disposable Barrier for Dental Hose | Dental Hose |
| | A880105 | Disposable Barrier for Universal Chair/X-
Ray Head | Universal Chair / X-Ray Head |
| | A880115 | Disposable Barrier for Multi-Purpose Use | Multi-Purpose Use |
| | 65090001 | DISPOSA-SHIELD® No. 1 Light Handles
and Control Panels, A880115 | Multi-Purpose Use |
| Element | Proposed Device | | Predicate Device |
| | Disposable Barrier Sleeves and Covers | | TIDIShield™ Curing Light Sleeve (K132953) |
| | Part
Number
(SKU) | Description | Designed For |
| | A88014 | Disposable Barrier for Tray Size 10 ½" x
14 ½" | Tray Size 10-1/2" x 14-1/2" |
| | A88015 | Disposable Barrier for Tray Size 12" x 17" | Tray Size 12" x 17" |
| | A88016 | Disposable Barrier for Dental Chair Head
Rest | Dental Chair Head Rest |
| | 65090004 | DISPOSA-SHIELD® No. 4 Headrest
Cover, A88016 | Dental Chair Head Rest |
| | A88018 | Disposable Barrier for Midwest RDH
Freedom Inner Module | Midwest RDH Freedom Inner Module |
| | A88019 | Disposable Barrier for Midwest RDH
Freedom with SmartMode Technology
Inner Module | Midwest RDH Freedom Cordless Prophy
System with SmartMode Technology |
| | 737007 | Disposable Barrier for Standard Type
Delivery Systems, Trial Pack for A88013 | Syringe Type Delivery Systems
Fits Delton FS+ Syringe |
| | 90736 | Disposable Barrier for Midwest RDH
Freedom Inner Module, Trial Pack for
A88018 | Midwest RDH Freedom Inner Module |
| | 978079 | Bebop Barrier Sleeve | Impression Material Dispenser |
| Element | Proposed Device
Disposable Barrier Sleeves and Covers | | Predicate Device
TIDIShield™ Curing
Light Sleeve (K132953) |
| | Models: | | |
| | Part
Number
(SKU) | Description | Designed For |
| | 050500 | Universal Digital Sensor Covers (Bulk) | RINN® Digital Sensor Covers, Size 1 and
Size 2 |
| | 550500 | Universal Digital Sensor Covers | RINN® Digital Sensor Covers, Size 1 and
Size 2 |
| | 550200 | Large Sensor Cover
(Soft Overbag Cover) | RINN® Large Digital Sensors
Sized to overbag sensor and sensor holder
(such as Snap-A-Ray DS) |
| | 550143 | Tight Digital Sensor Cover -
Size 1.5/2, 300-pack | Digital Sensors, size 1.5/2
Fits the following size 1.5 and 2 sensors:
Schick CDR, Schick 33, Dexis, Kodak
6100, Gendex eHd, Gendex GXS-700 |
| | 055574 | Tight Digital Sensor Cover -
Size 1.5/2, 25-pack | Digital Sensors, size 1.5/2
Fits the following size 1.5 and 2 sensors:
Schick CDR, Schick 33, Dexis, Kodak
6100, Gendex eHd, Gendex GXS-700 |
| | 055629 | Tight Digital Sensor Cover -
Size 1.5/ 2 | Digital Sensors, size 1.5/2
Fits the following size 1.5 and 2 sensors:
Schick CDR, Schick 33, Dexis, Kodak
6100, Gendex eHd, Gendex GXS-700 |
| | 550149 | Tight Sensor Cover –
Size 1, 300-pack | Digital Sensors, size 1
Fits the following size 1 sensors:
Planmeca, Instrumentarium, Schick,
Gendex, Kodak, Dentex |
| | 055575 | Tight Digital Sensor Cover -
Size 1, 25-pack | Digital Sensors, size 1
Fits the following size 1 sensors:
Planmeca, Instrumentarium, Schick,
Gendex, Kodak, Dentex |
| | 055630 | Tight Sensor Covers –
Size 1 | Digital Sensors, size 1
Fits the following size 1 sensors:
Planmeca, Instrumentarium, Schick,
Gendex, Kodak, Dentex |
| Element | Proposed Device
Disposable Barrier Sleeves and Covers | Predicate Device | |
| | Sani-Shield® and Sani-Tip® Barrier Sleeves and Covers are intended to serve as a
disposable barrier for dental instruments and equipment. This device is non-sterile and
intended for single patient use only.
Models: 120126, 130010 and 1300105 Disposable Barrier for Air/Water Syringes air
designed for Sani-Tip air/water syringe tips. | TIDIShield™ Curing
Light Sleeve (K132953) | |
| | Smartlite® Max Barrier Sleeves and Covers are intended to serve as a disposable
barrier for dental instruments and equipment. This device is non-sterile and intended
for single patient use only.
Model:
644060 SmartLite® Max Disposable Barrier Sleeves is designed for SmartLite® Max
L.E.D Curing Light.
644.50.030 SmartLite Focus Sleeve Refill is designed for Caulk K-156 SL Focus, SL
PS. | | |
| | Endo® Barrier Sleeves and Covers are intended to serve as a disposable barrier for
dental instruments and equipment. This device is non-sterile and intended for single
patient use only.
Model: EAPB100 (EAS100) EndoActivator Protective Barrier is designed for
EAD100 EndoActivator Handpiece/Driver. | | |
| | digit® power Barrier Sleeves and Covers are intended to serve as a disposable barrier
for dental instruments and equipment. This device is non-sterile and intended for single
patient use only.
Model: 678079 digit® power Disposable Barrier Sleeves Refill is designed for Aquasil
Ultra cordless Tissue Managing Impression System and Fits digit® power Dispenser. | | |
| Element | Proposed Device | Predicate Device | |
| | Disposable Barrier Sleeves and Covers | TIDIShield™ Curing
Light Sleeve (K132953) | |
| Material | Polyethylene film | Polyethylene film | |
| Material
Composition | Supplier #1 (PacDent): low density polyethylene and linear low density polyethylene film | Ethylene methyl acrylate
copolymer and low density
polyethylene film | |
| | Supplier #2 (MiniTube AB): low density polyethylene film | | |
| Biocompatibility | Supplier #1 (PacDent):
Non-cytotoxic
Non-sensitizing
Non-irritating | Non-cytotoxic
Non-sensitizing
Non-irritating | |
| | Supplier #2 (MiniTube AB):
Non-cytotoxic
Non-sensitizing
Non-irritating | | |
| Performance
Properties | Synthetic Blood Penetration- Pass
Synthetic Blood Penetration at seams and non-continuous components-Pass
Viral Penetration- Pass
Viral Penetration at seams and non-continuous components-Pass | Synthetic Blood Penetration-
Pass
Viral Penetration-Pass | |
| Mechanical
Properties | Tensile Strength
• 0.02mm-Acceptable
• 0.03mm-Acceptable
• 0.05mm-Comparable to predicate
Puncture Resistance
• 0.02mm-Acceptable
• 0.03mm-Acceptable
• 0.05mm-Comparable to predicate
Tear Resistance
• 0.02mm-Acceptable
• 0.03mm-Acceptable
• 0.05mm-Comparable to predicate | Tensile Strength
• 0.05mm- Acceptable
Puncture Resistance
• 0.05mm- Acceptable
Tear Resistance
• 0.05mm- Acceptable | |

13

14

15

16

17

ElementProposed DevicePredicate Device
Disposable Barrier Sleeves and CoversTIDIShield™ Curing Light Sleeve (K132953)
ThicknessPacDent: 0.02mm, 0.03mm, 0.05mm
MiniTube AB: 0.03mm0.05mm
ShapeCustom design to fit the intended dental instruments and equipment they cover
(Reference Table 5.3).Custom design to fit the intended instrument.
DimensionsDetermined by the size and shape of the dental instruments and equipment they cover
(Reference Table 5.3).Part # Length
(in) Width
(in) 21103 10 1/8" 2 3/16" 21102 10 1/8" 2 ¼" 21101 10 1/8" 2 ½" 21100 10 1/8" 2 3/16" Difference in Dimensions is
due to the difference in size
of the instruments they
cover.
ColorClear, except for RINN Tight Cover barrier sleeves
RINN Tight Cover barrier sleeves are clear with white tabs and blue tabs. Part numbers
550143, 055574, 055629, 550149, 05575, and 055630.Clear
SterileNot sterileNot sterile
Single UseSingle use deviceSingle use device

18

Part NumberDevice DescriptionSize
A88005Disposable Barrier for Low Speed, Contra-Angle Handpiece4.91 in. x 8.90 in.
65090003DISPOSA-SHIELD® No. 3 Air Turbines and Cavitron, A880054.91 in. x 8.90 in.
A88006Disposable Barrier for Low Speed, Long Handpiece1.56 in. x 7.60 in.
A88007Disposable Barrier for Universal Air/Water Syringe2.30 in. x 5.63 in.
65090002DISPOSA-SHIELD® No. 2 Air Motors, A880072.30 in. x 5.63 in.
A88008Disposable Barrier for Light Handle (T-Bar)2.94 in. x 6.81 in.
A88013Disposable Barrier for Standard Type Delivery Systems1.37 in. x 7.60 in.
A880095Disposable Barrier for Dental Hose2.1 in. x 24.0 in.
A880105Disposable Barrier for Universal Chair/X-Ray Head15 in. x 27.25 in.
A880115Disposable Barrier for Multi-Purpose Use4 in. x 6 in.
65090001DISPOSA-SHIELD® No. 1 Light Handles and Control Panels,
A8801154 in. x 6 in.
A88014Disposable Barrier for Tray Size 10 ½" x 14½"10.5 in. x 14.5 in.
A88015Disposable Barrier for Tray Size 12" x 17"12 in. x 17 in.
A88016Disposable Barrier for Dental Chair Head Rest13 in. x 13 in.
65090004DISPOSA-SHIELD® No. 4 Headrest Cover, A8801613 in. x 13 in.
A88018Disposable Barrier for Midwest RDH Freedom Inner Module59 mm x 178 mm
A88019Disposable Barrier for Midwest RDH Freedom with SmartMode
Technology Inner Module56.6 mm x 178
737007Disposable Barrier for Standard Type Delivery Systems, Trial Pack
for A880131.37 in. x 7.60 in.
90736Disposable Barrier for Midwest RDH Freedom Inner Module, Trial
Pack for A8801859 mm x 178 mm
978079Bebop Barrier Sleeve2.5 in. x 8.016 in.
050500Universal Digital Sensor Covers – Bulk Pack1.574 in. x 7.00
in.
550500Universal Digital Sensor Covers1.574 in. x 7.00
in.
550200Large Sensor Cover (Soft Overbag Cover)4.02 in. x 9.4 in.
550143Tight Digital Sensor Cover -Size 1.5/2, 300-pack8.881 in. x 1.772
in
055574Tight Digital Sensor Cover -Size 1.5/2, 25-pack8.881 in. x 1.772
in
055629Tight Digital Sensor Cover -Size 1.5/28.881 in. x 1.772
in
550149Tight Sensor Cover -Size 1, 300-pack8.881 in. x 1.713
in
Part NumberDevice DescriptionSize
055575Tight Sensor Cover - Size 1, 25-pack8.881 in. x 1.713 in
055630Tight Sensor Cover -Size 18.881 in. x 1.713 in
120126Sani-Shield® Disposable Barrier for Air/Water Syringe -Single Packs of 2502.25 in. x 8.50 in.
130010Sani-Shield® Disposable Barrier for Air/Water Syringe – 40 Single Packs of 2502.25 in. x 8.50 in.
1300105Sani-Shield® Disposable Barrier for Air/Water Syringe -Single Packs of 2502.25 in. x 8.50 in.
644060SmartLite® Max Disposable Barrier Sleeves2.125 in. x 10.813 in.
644.50.030SmartLite Focus Sleeve Refill11 in. x 1.75 in.
EAPB100Endo Activator Protective Barrier
678079digit® power Disposable Barrier Sleeves Refill2.189 in. x 8.5 in.

Table 5.3 Overall Dimensions (by Inches and Millimeters)

19

7. Non-Clinical Performance Data

| Test | Standard | Proposed Devices
Disposable Barrier
Sleeves and Covers | Predicate Device
TIDIShield™ Curing
Light Sleeve
(K132953) |
|-----------------------------------------------------------------------------|--------------------------|--------------------------------------------------------------|---------------------------------------------------------------------|
| Biocompatibility Testing: | | | |
| In-Vitro
Cytotoxicity | ANSI/AAMI/ISO
10993-5 | Pass | Pass |
| Sensitization | ISO 10993-10 | Pass | Pass |
| Irritation | ISO 10993-10 | Pass | Pass |
| Performance Testing: | | | |
| Synthetic Blood
Penetration | ASTM
F1670/F1670M | Pass | Pass |
| Synthetic Blood
Penetration at seams
and non-continuous
components | ASTM
F1670/F1670M | Pass | Pass |
| Viral Penetration | ASTM
F1671/F1671M | Pass | Pass |
| Viral Penetration at
seams and non-
continuous
components | ASTM
F1671/F1671M | Pass | Pass |

20

Biocompatibility testing focused on cytotoxicity, levels of skin sensitization and oral mucosa irritation of the proposed devices, Disposable Barrier Sleeves and Covers. Below is a summary of the testing performed:

  • ANSI AAMI ISO 10993-5 Biological Evaluation of Medical Devices-Part 5: ● Tests for In Vitro Cytotoxicity
  • ISO 10993-10 Biological Evaluation of Medical Devices-Part 10: Tests for . Irritation and Skin Sensitization

The performance of the proposed devices. Disposable Barrier Sleeves and Covers, met the requirements of the biocompatibility testing conducted to support substantial equivalence with the predicate, TIDIShield™ Curing Light Sleeve (K132953).

The performance testing (Bench) of the proposed devices, Disposable Barrier Sleeves and Covers, met the requirements of the non-clinical bench testing conducted to support substantial equivalence with the predicate, TIDIShield™ Curing Light Sleeve (K132953). Below is a summary of the testing performed:

  • ASTM F1670/F1670M Standard Test Method for Resistance of Materials Used in . Protective Clothing to Penetration by Synthetic Blood
  • ASTM F1671/ F1671M Standard Test Method for Resistance of Materials Used . in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System

| Mechanical
Property | Standard | Proposed Devices
Disposable Barrier
Sleeves and Covers | Predicate Device
TIDIShield™ Curing
Light Sleeve
(K132953) |
|------------------------|-----------------------|-----------------------------------------------------------------------------|---------------------------------------------------------------------|
| Tensile Strength | ASTM D882 | 0.02mm Acceptable
0.03mm Acceptable
0.05mm Comparable to
Predicate | Acceptable for
0.05mm |
| Puncture Resistance | ASTM
F1342/ F1342M | 0.02mm Acceptable
0.03mm Acceptable
0.05mm Comparable to
Predicate | Acceptable for
0.05mm |
| Tear Resistance | ASTM D1004 | 0.02mm Acceptable
0.03mm Acceptable
0.05mm Comparable to
Predicate | Acceptable for
0.05mm |

The range of mechanical properties for the samples is reported for the proposed devices. Disposable Barrier Sleeves and Covers. Below is a summary of the testing performed:

  • . ASTM D882 Standard Test Methods for Tensile Properties of Thin Plastic Sheeting
  • ASTM F1342/ F1342M Standard Test Method for Protective Clothing Material . Resistance to Puncture
  • ASTM D1004 Standard Test Method for Tear Resistance (Graves Tear) of Plastic . Film and Sheeting

21

The range of mechanical properties for the samples of the proposed devices. Disposable Barrier Sleeves and Covers, are comparable to those reported for the predicate device, TIDIShield™ Curing Light Sleeve (K132953), and support substantial equivalence with the predicate device, TIDIShield™ Curing Light Sleeve (K132953).

Clinical Performance Data.

No data from human clinical studies have been included to support the substantial equivalence of the proposed devices, Disposable Barrier Sleeves and Covers, as clinical studies are not required for this medical device.

8. Conclusion Regarding Substantial Equivalence

The proposed devices, Disposable Barrier Sleeves and Covers, are dental barrier sleeves and covers which are intended to serve as a disposable barrier for dental instruments and equipment. These disposable barrier sleeves and covers are non-sterile and are intended for single patient use only. The proposed devices, Disposable Barrier Sleeves and Covers, have the same intended use and indications for use and incorporate the same fundamental technology, as the predicate device, TIDIShield™ Curing Light Sleeve, cleared under premarket notification K132953. Test data to verify the performance of the proposed devices, Disposable Barrier Sleeves and Covers, have been provided including cytotoxicity, skin sensitization, oral mucosa irritation, synthetic blood penetration, synthetic blood penetration at seams and non-continuous components, viral penetration and viral penetration at seams and non-continuous components. The range of mechanical properties has been provided for puncture resistance, tear resistance, and tensile strength. The results of this testing, combined with the design, intended use and mechanical property comparison with the predicate device, support substantial equivalence with the predicate device, TIDIShield™ Curing Light Sleeve (K132953).