(310 days)
Not Found
No
The device description and performance studies focus on physical properties and barrier function, with no mention of AI/ML technologies.
No
The device is described as a barrier to cover dental instruments and surfaces, with no therapeutic action mentioned in its intended use or description.
No
The device description indicates that it is a barrier used to cover dental instruments and devices, intended to prevent contamination. The performance studies focus on physical properties and biocompatibility, not diagnostic capabilities. There is no mention of diagnostic functions or imaging in the provided text.
No
The device is a physical barrier made of polyethylene, 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 to "be used as a barrier to cover dental instruments." This is a physical barrier function, not a diagnostic test performed on samples taken from the human body.
- Device Description: The description reinforces the physical barrier function, covering instruments and devices.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies focus on the physical properties of the barrier (resistance to penetration, tear strength, etc.) and biocompatibility, which are relevant for a medical device but not specifically for an IVD.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Pac-Dent Barrier Sleeve and Cover-It Barrier Film are intended to be used as a barrier to cover dental instruments. This device is non-sterile and is intended for single patient use only.
| Item# | Model | Designed for |
|---|---|---|
| 101 | B tray sleeves | Dental instrument tray (size B) |
| 101A | A tray sleeves | Dental instrument tray (size A) |
| 102 | Headrest cover | Dental chair headrest, 11"X9 1/2" |
| 103 | Headrest cover | Dental chair headrest, jumbo, 14"X9 1/2" |
| 104 | F tray sleeves | Dental instrument tray (size F) |
| 109 | X-Ray sleeves | X-Ray head, universal, 15"X26" |
| 110 | Universal X-Ray sleeves | X-Ray head, universal, extra-long, 23"X31" |
| 111 | Full chair sleeves | Dental chair, universal, 29"X80" |
| 111SG | S&G full chair sleeves | Dental chair, Slip and Grip, 48"X56" |
| 112 | Half chair sleeves | Half dental chair, universal, 27 1/2"X24" |
| 100 | Syringe sleeve w. opening, clear | Air/water syringe HVE, universal |
| 100B | Syringe sleeve w. opening, blue | Air/water syringe HVE, universal |
| 100L | Digital sensor sleeve | Digital X-Ray sensor, universal, large, 1 5/8"X8" |
| 100S | Digital sensor sleeve | Digital X-Ray sensor, universal, small, 1 3/8"X8" |
| 103HP | High-speed handpiece sleeves | Dental high-speed handpiece, universal |
| 104HP | Low-speed handpiece sleeves | Dental low-speed handpiece, universal |
| 106 | "T" handle sleeves | T-style light handles, universal |
| 190LED | Sleeves for L.E. Demetron | Dental curing light (L.E. Demetron) |
| D250 | LED Curing light sleeves for Demi | Dental curing light (Demi) |
| S121 | Keyboard sleeves | Computer keyboard, universal, 22"X14" |
| S122 | Keyboard sleeves | Computer keyboard, large, 19"X26" |
| S123 | LCD & Keyboard sleeves | Computer screen and keyboard, universal |
| S124 | Laptop sleeves | Laptop, universal |
| LCH500 | Low-speed contra-angle handpiece sleeves w/paper backing | Dental low-speed contra-angle handpiece, universal |
| LLH500 | Low-speed long handpiece sleeves w/paper backing | Dental low-speed long handpiece, universal |
| CM500 | Optical PC mouse barriers | Computer mouse, universal |
| AWP400 | Syringe sleeve w/paper backing | Air/water syringe, universal |
| DX-405 | X-ray sensor sheaths, Gender,XDR® Size 1 | Digital X-Ray sensor (Gender,XDR® Size 1) |
| DX-406 | X-ray sensor sheaths, Gender,XDR® Size 2 | Digital X-Ray sensor (Gender,XDR® Size 2) |
| DX-819 | X-ray sensor sheaths, Suni/Lightyear | Digital X-Ray sensor (Suni/Lightyear) |
| DX-824 | X-ray sensor sheaths, Schick/Dr.Suni Plus | Digital X-Ray sensor (Schick/Dr.Suni Plus) |
| DX-825 | X-ray sensor sheaths, Schick/Dr.Suni Plus | Digital X-Ray sensor (Schick/Dr.Suni Plus) |
| DX-890 | X-ray sensor sheaths, Sirona Size 2 | Digital X-Ray sensor (Sirona Size 2) |
| DX-904 | X-ray sensor sheaths, Sirona Size 1 | Digital X-Ray sensor (Sirona Size 1 |
| DX-977 | X-ray sensor sheaths, Kodak 6100 Size 0 | Digital X-Ray sensor (Kodak 6100 Size 0) |
| DX-978 | X-ray sensor sheaths, Kodak 6100 Size 1 | Digital X-Ray sensor (Kodak 6100 Size 1) |
| DX-979 | X-ray sensor sheaths, Kodak 6100 Size 2 | Digital X-Ray sensor (Kodak 6100 Size 2) |
| DX-999 | X-ray sensor sheaths, Dexis | Digital X-Ray sensor (Dexis) |
| PIC250 | Complete iCure curing light sleeves | Dental curing light (iCure) |
| CS250 | Complete curing light sleeves | Dental curing light, universal |
| P3720 | Tube sleeves(2") | Dental unit tubing (2") |
| P3740 | Tube sleeves(4") | Dental unit tubing (4") |
| P4550 | Curing Light Handle Sleeves | Curing light handle, universal |
| C101 | Cover It™ Barrier film, clear | Surface area that might be touched during |
| procedure, 4"X6" | ||
| C101B | Cover It™ Barrier film, blue | Surface area that might be touched during |
| procedure, 4"X6" |
Product codes (comma separated list FDA assigned to the subject device)
PEM
Device Description
Pac-Dent Barrier Sleeve and Cover-It™ Barrier Film consist of various sizes and shapes of clear polyethylene covers which are positioned on various small hand-held dental instruments such as handpieces, curing lights, air/water syringes and similar hand instruments. In other forms, they are used to cover various devices such as dental chairs, dental instrument trays, x-ray heads, and others. The products are sold non-sterile, prepackaged, and are disposable, single use only.
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 test including resistance to penetration, tear strength, tensile properties, resistance to puncture was performed in comparison to the predicate device. Effectiveness of X-Ray Devices Covered with Barrier Sleeves was performed to demonstrate the subject device does not impact the function of dental x-ray devices.
Biocompatibility test in accordance with ISO10993-5, ISO10993-10 has been performed.
No clinical testing was provided.
The performance test result shows that the subject device performs as well as the predicate devices. The biocompatibility test result shows that the subject device was found to be not an irritant or a sensitizer and non -cytotoxic under the conditions of the studies.
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
§ 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 an abstract symbol that resembles three human profiles facing right, stacked on top of each other, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 3, 2016
Pac-Dent International, Inc. Wenying Zhu Materials Engineer 670 Endeavor Circle Brea, CA 92821
Re: K151123
Trade/Device Name: Pac-Dent Barrier Sleeve, Cover-It110 Barrier Film Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: PEM Dated: February 1, 2016 Received: February 4, 2016
Dear Ms. Zhu:
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
Page 2 - Ms. Zhu
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,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
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) K151123
Device Name
Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film
Indications for Use (Describe)
Pac-Dent Barrier Sleeve and Cover-It Barrier Film are intended to be used as a barrier to cover dental instruments. This device is non-sterile and is intended for single patient use only.
| Item# | Model | Designed for |
|---|---|---|
| 101 | B tray sleeves | Dental instrument tray (size B) |
| 101A | A tray sleeves | Dental instrument tray (size A) |
| 102 | Headrest cover | Dental chair headrest, 11"X9 1/2" |
| 103 | Headrest cover | Dental chair headrest, jumbo, 14"X9 1/2" |
| 104 | F tray sleeves | Dental instrument tray (size F) |
| 109 | X-Ray sleeves | X-Ray head, universal, 15"X26" |
| 110 | Universal X-Ray sleeves | X-Ray head, universal, extra-long, 23"X31" |
| 111 | Full chair sleeves | Dental chair, universal, 29"X80" |
| 111SG | S&G full chair sleeves | Dental chair, Slip and Grip, 48"X56" |
| 112 | Half chair sleeves | Half dental chair, universal, 27 1/2"X24" |
| 100 | Syringe sleeve w. opening, clear | Air/water syringe HVE, universal |
| 100B | Syringe sleeve w. opening, blue | Air/water syringe HVE, universal |
| 100L | Digital sensor sleeve | Digital X-Ray sensor, universal, large, 1 5/8"X8" |
| 100S | Digital sensor sleeve | Digital X-Ray sensor, universal, small, 1 3/8"X8" |
| 103HP | High-speed handpiece sleeves | Dental high-speed handpiece, universal |
| 104HP | Low-speed handpiece sleeves | Dental low-speed handpiece, universal |
| 106 | "T" handle sleeves | T-style light handles, universal |
| 190LED | Sleeves for L.E. Demetron | Dental curing light (L.E. Demetron) |
| D250 | LED Curing light sleeves for Demi | Dental curing light (Demi) |
| S121 | Keyboard sleeves | Computer keyboard, universal, 22"X14" |
| S122 | Keyboard sleeves | Computer keyboard, large, 19"X26" |
| S123 | LCD & Keyboard sleeves | Computer screen and keyboard, universal |
| S124 | Laptop sleeves | Laptop, universal |
| LCH500 | Low-speed contra-angle handpiece sleeves w/paper backing | Dental low-speed contra-angle handpiece, universal |
| LLH500 | Low-speed long handpiece sleeves w/paper backing | Dental low-speed long handpiece, universal |
| CM500 | Optical PC mouse barriers | Computer mouse, universal |
| AWP400 | Syringe sleeve W/paper backing | Air/water syringe, universal |
| DX-405 | X-ray sensor sheaths, Gender,XDR® Size 1 | Digital X-Ray sensor (Gender,XDR® Size 1) |
| DX-406 | X-ray sensor sheaths, Gender,XDR® Size 2 | Digital X-Ray sensor (Gender,XDR® Size 2) |
| DX-819 | X-ray sensor sheaths, Suni/Lightyear | Digital X-Ray sensor (Suni/Lightyear) |
| DX-824 | X-ray sensor sheaths, Schick/Dr.Suni Plus | Digital X-Ray sensor (Schick/Dr.Suni Plus) |
| DX-825 | X-ray sensor sheaths, Schick/Dr.Suni Plus | Digital X-Ray sensor (Schick/Dr.Suni Plus) |
| DX-890 | X-ray sensor sheaths, Sirona Size 2 | Digital X-Ray sensor (Sirona Size 2) |
| DX-904 | X-ray sensor sheaths, Sirona Size 1 | Digital X-Ray sensor (Sirona Size 1) |
| DX-977 | X-ray sensor sheaths, Kodak 6100 Size 0 | Digital X-Ray sensor (Kodak 6100 Size 0) |
| DX-978 | X-ray sensor sheaths, Kodak 6100 Size 1 | Digital X-Ray sensor (Kodak 6100 Size 1) |
| DX-979 | X-ray sensor sheaths, Kodak 6100 Size 2 | Digital X-Ray sensor (Kodak 6100 Size 2) |
| DX-999 | X-ray sensor sheaths, Dexis | Digital X-Ray sensor (Dexis) |
| PIC250 | Complete iCure curing light sleeves | Dental curing light (iCure) |
| CS250 | Complete curing light sleeves | Dental curing light, universal |
| P3720 | Tube sleeves(2") | Dental unit tubing (2") |
| P3740 | Tube sleeves(4") | Dental unit tubing (4") |
| P4550 | Curing Light Handle Sleeves | Curing light handle, universal |
| C101 | Cover It Barrier film, clear | Surface area that might be touched during |
| procedure, 4"X6" | ||
| C101B | Cover It Barrier film, blue | Surface area that might be touched during |
| procedure, 4"X6" |
3
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the logo for PacDent. The logo features the company name in a bold, blue font. Above the company name is an orange swoosh that curves over the top of the text. The logo is simple and modern, and the colors are eye-catching.
Pac-Dent International, Inc.
510(k) Summary
Submitter:
Pac-Dent International, Inc. 670 Endeavor Circle Brea, CA 92821 Contact Person: Wenying Zhu Materials Engineer 909-839-0888 ext.111 Date Summary Prepared: 02/15/2016
Device Name
Trade Name: Pac-Dent Barrier Sleeve, Cover-It™ Barrier Film Common Name: Dental Barriers and Sleeves Device Classification: Class II Classification Product Code: PEM Classification Name: Surgical drape and drape accessories per 21 CFR 878.4370
Predicate Device
Primary predicate device: TiDiShield Curing Light Sleeve - K132953 Reference Device: Cover-All, Chair Sleeve, Drape-it-All, Tray Sleeve, related products - K962288
Description of Device
Pac-Dent Barrier Sleeve and Cover-It™ Barrier Film consist of various sizes and shapes of clear polyethylene covers which are positioned on various small hand-held dental instruments such as handpieces, curing lights, air/water syringes and similar hand instruments. In other forms, they are used to cover various devices such as dental chairs, dental instrument trays, x-ray heads, and others. The products are sold non-sterile, prepackaged, and are disposable, single use only.
Indications for Use
Pac-Dent Barrier Sleeve and Cover-It™ Barrier Film are intended to be used as a barrier to cover dental instruments. This device is non-sterile and is intended for single patient use only.
| Item# | Model | Designed for |
|---|---|---|
| 101 | B tray sleeves | Dental instrument tray (size B) |
| 101A | A tray sleeves | Dental instrument tray (size A) |
| 102 | Headrest cover | Dental chair headrest, 11"X9 1/2" |
| 103 | Headrest cover | Dental chair headrest, jumbo, 14"X9 1/2" |
| 104 | F tray sleeves | Dental instrument tray (size F) |
| 109 | X-Ray sleeves | X-Ray head, universal, 15"X26" |
| 110 | Universal X-Ray sleeves | X-Ray head, universal, extra-long, 23"X31" |
| 111 | Full chair sleeves | Dental chair, universal, 29"X80" |
| 111SG | S&G full chair sleeves | Dental chair, Slip and Grip, 48"X56" |
| 112 | Half chair sleeves | Half dental chair, universal, 27 1/2"X24" |
| 100 | Syringe sleeve w. opening, clear | Air/water syringe HVE, universal |
| 100B | Syringe sleeve w. opening, blue | Air/water syringe HVE, universal |
| 100L | Digital sensor sleeve | Digital X-Ray sensor, universal, large, 1 5/8"X8" |
| 100S | Digital sensor sleeve | Digital X-Ray sensor, universal, small, 1 3/8"X8" |
| 103HP | High-speed handpiece sleeves | Dental high-speed handpiece, universal |
| 104HP | Low-speed handpiece sleeves | Dental low-speed handpiece, universal |
| 106 | "T" handle sleeves | T-style light handles, universal |
| 190LED | Sleeves for L.E. Demetron | Dental curing light (L.E. Demetron) |
| D250 | LED Curing light sleeves for Demi | Dental curing light (Demi) |
| S121 | Keyboard sleeves | Computer keyboard, universal, 22"X14" |
| S122 | Keyboard sleeves | Computer keyboard, large, 19"X26" |
| S123 | LCD & Keyboard sleeves | Computer screen and keyboard, universal |
| S124 | Laptop sleeves | Laptop, universal |
| LCH500 | Low-speed contra-angle handpiece sleeves w/paper backing | Dental low-speed contra-angle handpiece, universal |
| LLH500 | Low-speed long handpiece sleeves w/paper backing | Dental low-speed long handpiece, universal |
| CM500 | Optical PC mouse barriers | Computer mouse, universal |
| AWP400 | Syringe sleeve w/paper backing | Air/water syringe, universal |
| DX-405 | X-ray sensor sheaths, Gender,XDR® Size 1 | Digital X-Ray sensor (Gender,XDR® Size 1) |
| DX-406 | X-ray sensor sheaths, Gender,XDR® Size 2 | Digital X-Ray sensor (Gender,XDR® Size 2) |
| DX-819 | X-ray sensor sheaths, Suni/Lightyear | Digital X-Ray sensor (Suni/Lightyear) |
| DX-824 | X-ray sensor sheaths, Schick/Dr.Suni Plus | Digital X-Ray sensor (Schick/Dr.Suni Plus) |
| DX-825 | X-ray sensor sheaths, Schick/Dr.Suni Plus | Digital X-Ray sensor (Schick/Dr.Suni Plus) |
| DX-890 | X-ray sensor sheaths, Sirona Size 2 | Digital X-Ray sensor (Sirona Size 2) |
| DX-904 | X-ray sensor sheaths, Sirona Size 1 | Digital X-Ray sensor (Sirona Size 1 |
| DX-977 | X-ray sensor sheaths, Kodak 6100 Size 0 | Digital X-Ray sensor (Kodak 6100 Size 0) |
| DX-978 | X-ray sensor sheaths, Kodak 6100 Size 1 | Digital X-Ray sensor (Kodak 6100 Size 1) |
| DX-979 | X-ray sensor sheaths, Kodak 6100 Size 2 | Digital X-Ray sensor (Kodak 6100 Size 2) |
| DX-999 | X-ray sensor sheaths, Dexis | Digital X-Ray sensor (Dexis) |
| PIC250 | Complete iCure curing light sleeves | Dental curing light (iCure) |
| CS250 | Complete curing light sleeves | Dental curing light, universal |
| P3720 | Tube sleeves(2") | Dental unit tubing (2") |
| P3740 | Tube sleeves(4") | Dental unit tubing (4") |
| P4550 | Curing Light Handle Sleeves | Curing light handle, universal |
| C101 | Cover It™ Barrier film, clear | Surface area that might be touched during |
| procedure, 4"X6" | ||
| C101B | Cover It™ Barrier film, blue | Surface area that might be touched during |
| procedure, 4"X6" |
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Image /page/5/Picture/0 description: The image contains the logo for PacDent. The logo features the company name in a bold, blue font. Above the company name is an orange swoosh design.
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Image /page/6/Picture/0 description: The image contains the logo for Pac-Dent International, Inc. The logo features the company name in a combination of blue and gray text. To the left of the company name is an orange graphic element that appears to be a stylized swoosh or arc.
Comparison of Technological Characteristics and Performance
| Descriptive
| Information | Subject Device | Primary Predicate Device | Reference Device |
|---|---|---|---|
| Pac-Dent Barrier Sleeve, Cover-It™ | |||
| Barrier Film | TiDiShield Curing Light Sleeve | ||
| (K132953) | Cover-All (K962288) | ||
| Indications for | |||
| Use | To be used as a barrier to cover | ||
| dental instruments. | Use as a barrier that is used as | ||
| an accessory to dental | |||
| instrument. | To act as a physical barrier, | ||
| augmenting existing infection | |||
| control techniques and make | |||
| clean-up and disinfection | |||
| easier. | |||
| Classification | |||
| Product Code | PEM | PEM | MMP |
| Composition of | |||
| Materials | LLDPE (80%) | ||
| LDPE (20%) | |||
| Blue pigment (item#100B, C101B) | |||
| Adhesive (item#C101, C101B) | LLDPE (80%) | ||
| LDPE (20%) | LLDPE (80%) | ||
| LDPE (20%) | |||
| Specifications | |||
| and Tolerances | Paper backing: some of the model | ||
| Film thickness: 0.02-0.06mm | |||
| Tolerance: |