Disposable Barrier Sleeves and Covers

K160232 · Dentsply International, Inc. · PEM · Jun 7, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K160232
• Device Name: Disposable Barrier Sleeves and Covers
• Applicant: Dentsply International, Inc.
• Product Code: PEM · General, Plastic Surgery
• Decision Date: Jun 7, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

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 Story

Disposable barrier sleeves and covers made of polyethylene film; designed to fit over various dental instruments and equipment (e.g., handpieces, air/water syringes, light handles, trays, headrests, digital sensors). Used in dental clinics to provide a physical barrier against contaminants, augmenting infection control and facilitating clean-up. Operated by dental staff. Output is a protective film layer; affects clinical decision-making by ensuring equipment hygiene and reducing cross-contamination risk. Benefits patient by minimizing exposure to pathogens during dental procedures.

Clinical Evidence

No clinical data provided; substantial equivalence supported by non-clinical bench testing.

Technological Characteristics

Materials: Polyethylene film (low density and linear low density). Sensing/actuation: None (passive barrier). Dimensions: Various custom shapes/sizes. Connectivity: None. Sterilization: Non-sterile. Standards: ASTM F1670/F1670M (synthetic blood), ASTM F1671/F1671M (viral penetration), ASTM D882 (tensile), ASTM F1342/F1342M (puncture), ASTM D1004 (tear), ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization/irritation).

Indications for Use

Indicated for use as a disposable barrier for dental instruments and equipment to augment infection control and facilitate clean-up during dental procedures. Intended for single patient use.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• TIDIShield™ Curing Light Sleeve (K132953)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# 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)

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| | Disposa-Shield® Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instruments<br>and equipment. This device is non-sterile and intended for single patient use only. | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Models: | | | |
| Part Number<br>(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<br>Cavitron, A88005 | Fits Cavitron Handpiece<br>Low Speed, Contra-Angle Handpieces<br>Fits Cavitron Handpiece | |
| A88006 | Disposable Barrier for Low Speed, Long Handpiece | Low Speed, Long Handpieces<br>Fits: SmartLite PS, Tulsa 6:1,<br>Contra Angle Handpiece by Sirona,<br>e³ Torque Control Motor, MIDWEST Handpiece | |
| A88007 | Disposable Barrier for Universal Air/Water Syringe | Universal Air/Water Syringe<br>(syringe type delivery system) | |
| 65090002 | DISPOSA-SHIELD® No. 2 Air Motors, A88007 | Universal Air/Water Syringe<br>(syringe type delivery system) | |
| A88008 | Disposable Barrier for Light Handle (T-Bar) | Light Handle (T-Bar) | |
| A88013 | Disposable Barrier for Standard Type Delivery<br>Systems | Syringe Type Delivery Systems<br>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<br>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<br>Module | Midwest RDH Freedom Inner Module | |
| A88019 | Disposable Barrier for Midwest RDH Freedom with<br>SmartMode Technology Inner Module | Midwest RDH Freedom Cordless Prophy System with<br>SmartMode Technology | |
| Part Number (SKU) | Description | Designed For | |
| 737007 | Disposable Barrier for Standard Type Delivery Systems, Trial Pack for A88013 | Syringe Type Delivery Systems<br>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:<br>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<br>(Soft Overbag Cover) | RINN® Large Digital Sensors<br>Sized to overbag sensor and sensor holder (such as Snap-A-Ray DS) | |
| 550143 | Tight Digital Sensor Cover –<br>Size 1.5/2, 300-pack | Digital Sensors, size 1.5/2<br>Fits the following size 1.5 and 2 sensors:<br>Schick CDR, Schick 33, Dexis, Kodak 6100, Gendex eHd, Gendex GXS-700 | |
| 055574 | Tight Digital Sensor Cover –<br>Size 1.5/2, 25-pack | Digital Sensors, size 1.5/2<br>Fits the following size 1.5 and 2 sensors:<br>Schick CDR, Schick 33, Dexis, Kodak 6100, Gendex eHd, Gendex GXS-700 | |
| 055629 | Tight Digital Sensor Cover –<br>Size 1.5/2 | Digital Sensors, size 1.5/2<br>Fits the following size 1.5 and 2 sensors:<br>Schick CDR, Schick 33, Dexis, Kodak 6100, Gendex eHd, Gendex GXS-700 | |
| 550149 | Tight Sensor Cover –<br>Size 1, 300-pack | Digital Sensors, size 1<br>Fits the following size 1 sensors:<br>Planmeca, Instrumentarium, Schick, Gendex, Kodak, Dentex | |
| Part Number<br>(SKU) | Description | Designed For | |
| 055575 | Tight Digital Sensor Cover -<br>Size 1, 25-pack | Digital Sensors, size 1<br>Fits the following size 1 sensors:<br>Planmeca, Instrumentarium, Schick, Gendex, Kodak,<br>Dentex | |
| 055630 | Tight Sensor Covers –<br>Size 1 | Digital Sensors, size 1<br>Fits the following size 1 sensors:<br>Planmeca, Instrumentarium, Schick, Gendex, Kodak,<br>Dentex | |
| | Sani-Shield® and Sani-Tip® Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental<br>instruments and equipment. This device is non-sterile and intended for single patient use only.<br>Models: 120126, 130010 and 1300105 Disposable Barrier for Air/Water Syringes air designed for Sani-Tip<br>air/water syringe tips. | | |
| | Smartlite® Max Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instruments<br>and equipment. This device is non-sterile and intended for single patient use only.<br>Model:<br>644060 SmartLite® Max Disposable Barrier Sleeves is designed for SmartLite® Max L.E.D Curing Light.<br>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<br>equipment. This device is non-sterile and intended for single patient use only.<br>Model: EAPB100 (EAS100) EndoActivator Protective Barrier is designed for EAD100 EndoActivator<br>Handpiece/Driver. | | |
| | digit® power Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instruments<br>and equipment. This device is non-sterile and intended for single patient use only.<br>Model: 678079 digit® power Disposable Barrier Sleeves Refill is designed for Aquasil Ultra cordless Tissue<br>Managing Impression System and Fits digit® power Dispenser. | | |

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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 Name | 510(k) | Company Name |
|------------------------------------|---------|--------------------|
| TIDIShield™ Curing<br>Light Sleeve | K132953 | TIDI 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.

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#### 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<br>Number<br>(SKU) | Description | Designed For |
|-------------------------|-----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| A88005 | Disposable Barrier for Low Speed, Contra-Angle Handpiece | Low Speed, Contra-Angle Handpieces<br>Fits Cavitron Handpiece |
| 65090003 | DISPOSA-SHIELD® No. 3 Air Turbines and<br>Cavitron, A88005 | Low Speed, Contra-Angle Handpieces<br>Fits Cavitron Handpiece |
| A88006 | Disposable Barrier for Low Speed, Long<br>Handpiece | Low Speed, Long Handpieces<br>Fits:<br>SmartLite PS<br>Tulsa 6:1,<br>ContraAngle Handpiece by Sirona<br>e3 Torque Control Motor<br>MIDWEST Handpiece |
| A88007 | Disposable Barrier for Universal Air/Water<br>Syringe | Universal Air/Water Syringe<br>(syringe type delivery system) |
| 65090002 | DISPOSA-SHIELD® No. 2 Air Motors,<br>A88007 | Universal Air/Water Syringe<br>(syringe type delivery system) |
| A88008 | Disposable Barrier for Light Handle (T-Bar) | Light Handle (T-Bar) |
| A88013 | Disposable Barrier for Standard Type Delivery<br>Systems | Syringe Type Delivery Systems<br>Fits Delton FS+ Syringe |
| A880095 | Disposable Barrier for Dental Hose | Dental Hose |
| A880105 | Disposable Barrier for Universal Chair/X-Ray<br>Head | Universal Chair / X-Ray Head |
| A880115 | Disposable Barrier for Multi-Purpose Use | Multi-Purpose Use |
| 65090001 | DISPOSA-SHIELD® No. 1 Light Handles and<br>Control Panels, A880115 | Multi-Purpose Use |
| A88014 | Disposable Barrier for Tray Size 10 $^{1}\!/_{2}$ " x 14<br>$^{1}\!/_{2}$ " | Tray Size 10-1/2" x 14-1/2" |
| Part<br>Number<br>(SKU) | Description | Designed For |
| 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,<br>A88016 | Dental Chair Head Rest |
| A88018 | Disposable Barrier for Midwest RDH Freedom<br>Inner Module | Midwest RDH Freedom Inner Module |
| A88019 | Disposable Barrier for Midwest RDH Freedom<br>with SmartMode Technology Inner Module | Midwest RDH Freedom Cordless<br>Prophy System with SmartMode<br>Technology Inner Module |
| 737007 | Disposable Barrier for Standard Syringe Type<br>Delivery Systems, Trial Pack for A88013 | Syringe Type Delivery Systems<br>Fits Delton FS+ Syringe |
| 90736 | Disposable Barrier for Midwest RDH Freedom<br>Inner Module, Trial Pack for A88018 | Midwest RDH Freedom Inner Module |
| 978079 | Bebop Barrier Sleeve | Impression Material Dispenser |

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

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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.

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#### 6. Substantial Equivalence:

# Table 5.2 Technological Characteristics

| Element | Proposed Device | Predicate Device |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Disposable Barrier Sleeves and Covers | TIDIShield™ Curing<br>Light Sleeve (K132953) |
| 510(k) | To be assigned | K132953 |
| Indications for<br>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.<br><br>See the attached table for the product names, trade names and model numbers. | TIDIShield™ Curing<br>Light Sleeves are<br>indicated for use as a<br>barrier that is used as an<br>accessory to dental<br>instrument. These sleeves<br>are non-sterile and are<br>intended for single patient<br>only. |

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| Element | Proposed Device<br>Disposable Barrier Sleeves and Covers | | Predicate Device |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Disposa-Shield® Barrier Sleeves and Covers are intended to serve as a disposable<br>barrier for dental instruments and equipment. This device is non-sterile and intended<br>for single patient use only.<br>Models: | | TIDIShield™ Curing<br>Light Sleeve (K132953) |
| | Part<br>Number<br>(SKU) | Description | Designed For |
| | A88005 | Disposable Barrier for Low Speed, Contra-Angle Handpiece | Low Speed, Contra-Angle Handpieces<br>Fits Cavitron Handpiece |
| | 65090003 | DISPOSA-SHIELD® No. 3 Air Turbines<br>and Cavitron, A88005 | Low Speed, Contra-Angle Handpieces<br>Fits Cavitron Handpiece |
| | A88006 | Disposable Barrier for Low Speed, Long<br>Handpiece | Low Speed, Long Handpieces<br>Fits: SmartLite PS,Tulsa 6:1,<br>ContraAngle Handpiece by Sirona,<br>e³ Torque Control Motor, MIDWEST<br>Handpiece |
| | A88007 | Disposable Barrier for Universal<br>Air/Water Syringe | Universal Air/Water Syringe<br>(syringe type delivery system) |
| | 65090002 | DISPOSA-SHIELD® No. 2 Air Motors,<br>A88007 | Universal Air/Water Syringe<br>(syringe type delivery system) |
| | A88008 | Disposable Barrier for Light Handle (T-<br>Bar) | Light Handle (T-Bar) |
| | A88013 | Disposable Barrier for Standard Type<br>Delivery Systems | Syringe Type Delivery Systems<br>Fits Delton FS+ Syringe |
| | A880095 | Disposable Barrier for Dental Hose | Dental Hose |
| | A880105 | Disposable Barrier for Universal Chair/X-<br>Ray Head | Universal Chair / X-Ray Head |
| | A880115 | Disposable Barrier for Multi-Purpose Use | Multi-Purpose Use |
| | 65090001 | DISPOSA-SHIELD® No. 1 Light Handles<br>and Control Panels, A880115 | Multi-Purpose Use |
| Element | Proposed Device | | Predicate Device |
| | Disposable Barrier Sleeves and Covers | | TIDIShield™ Curing Light Sleeve (K132953) |
| | Part<br>Number<br>(SKU) | Description | Designed For |
| | A88014 | Disposable Barrier for Tray Size 10 ½" x<br>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<br>Rest | Dental Chair Head Rest |
| | 65090004 | DISPOSA-SHIELD® No. 4 Headrest<br>Cover, A88016 | Dental Chair Head Rest |
| | A88018 | Disposable Barrier for Midwest RDH<br>Freedom Inner Module | Midwest RDH Freedom Inner Module |
| | A88019 | Disposable Barrier for Midwest RDH<br>Freedom with SmartMode Technology<br>Inner Module | Midwest RDH Freedom Cordless Prophy<br>System with SmartMode Technology |
| | 737007 | Disposable Barrier for Standard Type<br>Delivery Systems, Trial Pack for A88013 | Syringe Type Delivery Systems<br>Fits Delton FS+ Syringe |
| | 90736 | Disposable Barrier for Midwest RDH<br>Freedom Inner Module, Trial Pack for<br>A88018 | Midwest RDH Freedom Inner Module |
| | 978079 | Bebop Barrier Sleeve | Impression Material Dispenser |
| Element | Proposed Device<br>Disposable Barrier Sleeves and Covers | | Predicate Device<br>TIDIShield™ Curing<br>Light Sleeve (K132953) |
| | Models: | | |
| | Part<br>Number<br>(SKU) | Description | Designed For |
| | 050500 | Universal Digital Sensor Covers (Bulk) | RINN® Digital Sensor Covers, Size 1 and<br>Size 2 |
| | 550500 | Universal Digital Sensor Covers | RINN® Digital Sensor Covers, Size 1 and<br>Size 2 |
| | 550200 | Large Sensor Cover<br>(Soft Overbag Cover) | RINN® Large Digital Sensors<br>Sized to overbag sensor and sensor holder<br>(such as Snap-A-Ray DS) |
| | 550143 | Tight Digital Sensor Cover -<br>Size 1.5/2, 300-pack | Digital Sensors, size 1.5/2<br>Fits the following size 1.5 and 2 sensors:<br>Schick CDR, Schick 33, Dexis, Kodak<br>6100, Gendex eHd, Gendex GXS-700 |
| | 055574 | Tight Digital Sensor Cover -<br>Size 1.5/2, 25-pack | Digital Sensors, size 1.5/2<br>Fits the following size 1.5 and 2 sensors:<br>Schick CDR, Schick 33, Dexis, Kodak<br>6100, Gendex eHd, Gendex GXS-700 |
| | 055629 | Tight Digital Sensor Cover -<br>Size 1.5/ 2 | Digital Sensors, size 1.5/2<br>Fits the following size 1.5 and 2 sensors:<br>Schick CDR, Schick 33, Dexis, Kodak<br>6100, Gendex eHd, Gendex GXS-700 |
| | 550149 | Tight Sensor Cover –<br>Size 1, 300-pack | Digital Sensors, size 1<br>Fits the following size 1 sensors:<br>Planmeca, Instrumentarium, Schick,<br>Gendex, Kodak, Dentex |
| | 055575…