(148 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of polyethylene covers, with no mention of AI or ML technology.
No
The device is a disposable barrier for dental instruments and equipment, not a device intended to treat or diagnose a medical condition.
No
The device is described as a disposable barrier for dental instruments and equipment, designed to cover various dental instruments and devices. It does not perform any diagnostic function.
No
The device description explicitly states it consists of physical polyethylene covers, 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 a "disposable barrier for dental instruments and equipment." This is a physical barrier to prevent contamination, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details physical covers made of polyethylene. This aligns with the function of a barrier, not an in vitro diagnostic test.
- Performance Studies: The performance studies focus on physical properties like resistance to penetration, tear resistance, tensile strength, and puncture resistance, as well as biocompatibility and impact on the function of covered devices. These are relevant to a barrier device, not an IVD.
IVD devices are typically used to test samples like blood, urine, tissue, etc., outside of the body to detect diseases, conditions, or infections. This device does not perform any such testing.
N/A
Intended Use / Indications for Use
Dental Barrier and Sleeves are intended to be used as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.
Product codes
PEM
Device Description
Dental Barrier and Sleeves consist of various sizes and shapes of polyethylene covers which are positioned on various small hand-held dental instruments such as hand pieces, 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 resistance, tensile strength, puncture resistance was performed. Biocompatibility test in accordance with ISO 10993-10 and ISO 10993-23 has been performed. Effectiveness of x-ray devices covered with Dental Barrier and Sleeves were performed to demonstrate the subject device does not impact the function of dental x-ray devices.
The biocompatibility test result indicates that the barrier sleeves do not have the potential cytotoxicity, sensitization and irritation.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
May 9, 2024
Yongqing Huaguan Dental Instruments Factory % Jarvis Wu Senior Consultant Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave Shanghai, Shanghai 200122 CHINA
Re: K233918
Trade/Device Name: Dental Barrier and Sleeves Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape And Drape Accessories Regulatory Class: Class II Product Code: PEM Dated: April 10, 2024 Received: April 10, 2024
Dear Jarvis Wu:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
that may require a new premarket notification are provided in the FDA
Page
2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Michael E. Adjodha -S
Michael Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Dental Barrier and Sleeves
Indications for Use (Describe)
Dental Barrier and Sleeves are intended to be used 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 model numbers and descriptions in 510(k) Summary.
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)
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4
Intersection Of Ronghua Road And Siwei Street, Yongoing Industrial Area, Langfang City,065600,Hebei, China
510(K) Summary
K233918
Document prepared date: 2024/04/10
A. Applicant:
Yongqing Huaguan Dental Instruments Factory Address: Intersection Of Ronghua Road And Siwei Street. Yongqing Industrial Area. Langfang City,065600,Hebei, China Contact Person: Ms. ZengYan Wu Title: Sales Manager Tel: +0086-316-6659888 Fax: +0086-316-6659111 Email: hbhls1@126.com
Submission Correspondent: Primary contact: Mr. Jarvis Wu Title: Senior Consultant Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: jiawei.wu@sungoglobal.com
Secondary contact: Mr. Raymond Luo Title: Technical Director Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: zxfda@sungoglobal.com
B. Device:
Trade Name: Dental Barrier and Sleeves Common Name: Dental Barrier and Sleeves
Regulatory Information Classification Name: Surgical Drape And Drape Accessories Classification: Class II Product code: PEM Regulation Number: 21 CFR 878.4370
C. Predicate device:
Predicate Device: K190484 Product name: BH Medical Dental Barrier Sleeves and Barrier Film Manufacturer: BH Medical Products Co., Ltd.
D. Intended use of the device:
Dental Barrier and Sleeves are intended to be used as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only
5
Intersection Of Ronghua Road And Siwei Street, Yongoing Industrial Area, Langfang City,065600,Hebei, China
E. Device Description:
Dental Barrier and Sleeves consist of various sizes and shapes of polyethylene covers which are positioned on various small hand-held dental instruments such as hand pieces, 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.
| Item | Model# | Model Description | Designed for | ||
|---|---|---|---|---|---|
| Models for intra-orally use (Subject to this 510k submission) | |||||
| 1 | HL-6562/ | ||||
| HL-6563 | Air/Water Syringe Sleeves | Air/Water Syringe, HVE Universal 2-1/2 " ×10 " | |||
| 2 | HL-6564 | Month Mirror Covers or | |||
| Sleeves | Dental Mirror 1-1/2 " ×8 " | ||||
| 3 | HL-6565 | Low Speed Handpiece | |||
| Sleeves | Dental Low-Speed Handpiece Universal 1-1/2 " ×8 " | ||||
| 4 | HL-6566 | High Speed Handpiece | |||
| Sleeves | Dental High-Speed Handpiece Universal 1 " ×8 " | ||||
| 5 | HL-6577 | X-Ray Covers | X-Ray Universal 15 " ×26 " | ||
| 6 | HL-6578 | 3 - function sprayer Sleeves | 3-Fuction Sprayer 7-3/10 " ×5 " | ||
| 7 | HL-6579 | Scaler Covers | Dental Scaler 1-3/5 " ×8 " | ||
| 8 | HL-6580 | Intraoral Camera Sheath | Intraoral Camera 9-4/5 " ×2 " | ||
| 9 | HL-6581 | Digital X-ray Sensor Covers | Digital X-Ray Sensor, Universal 2-1/2 " ×10 " | ||
| 10 | HL-6582-1 | Digital X-ray Sensor Covers | Digital X-Ray Sensor, Universal 8 " ×1-5/8 " | ||
| 11 | HL-6582-2 | Digital X-ray Sensor Covers | Digital X-Ray Sensor, Universal 8 " ×1-3/8 " | ||
| 12 | HL-6585 | Syringe Sleeves (Roll bag) | Syringe 2.2 " ×17.7 " | ||
| 13 | HL-6586 | Turbine Motor Sleeves (Roll | |||
| bag) | Turbine 1.8 " ×17.7 " | ||||
| 14 | HL-6588S | Curing Light Sleeves | Dental Curing Light 4.33"X2.95" | ||
| 15 | HL-6588L | Curing Light Sleeves | Dental Curing Light 4.33"X2.95" | ||
| 16 | HL-6597 | Curing Light Sleeves | Dental Curing Light 4.7" ×1.2" | ||
| 17 | HL-6592 | Curing Light Sleeves | Dental Curing Light 13 " ×2.1 " | ||
| 18 | HL-6593 | Curing Light Sleeves | Dental Curing Light 13 " ×3.3 " | ||
| 19 | HL-6594 | Intraoral Camera Sleeve | Intraoral Camera 10.2 " ×2 " | ||
| 20 | HL-6595 | Curing Light Sleeves | Dental Curing Light 9.9"X1.85" | ||
| 21 | HL-6596 | Curing Light Sleeves | Dental Curing Light 12.4"X4.13" | ||
| 22 | HL-6604 | Disposable Barrier Sleeves | Barrier Sleeve 9.25 " ×3.15 " | ||
| 23 | HL-6605 | Disposable Barrier Sleeves | Barrier Sleeve 11.2 " ×2.2 " | ||
| 24 | HL-6606 | Disposable Barrier Sleeves | Barrier Sleeve 11.2 " ×2.2 " |
Table for the model numbers and descriptions :
6
Intersection Of Ronghua Road And Siwei Street, Yongqing Industrial Area, Langfang City,065600,Hebei, China
| 25 | HL-6607 | Low Speed Handpiece Cover | Low Speed Handpiece 7.5 "x1.53 " |
|---|---|---|---|
| 26 | HL-6608 | X-ray sensors Cover | X-Ray Sensor 8 " x1-5/8 " |
| 27 | HL-6610 | Digital Sensor Envelopes | Digital Sensor 2"X4.5" |
| 28 | HL-6611 | Digital Sensor Envelopes | Digital Sensor 1-5/8"X4" |
| 29 | HL-6612 | Digital Sensor Envelopes | Digital Sensor 1.6"X4.5" |
| 30 | HL-6613 | Digital Sensor Envelopes | Digital Sensor 1.4"X4.3" |
| 31 | HL-6614 | Bite Block Covers | Bite Block 1.4"X2.5" |
| 32 | HL-6615 | Intraoral Camera Sleeve | Intraoral Camera 35mm*110mm |
| 33 | HL-6579S | Scaler Covers | Dental Scaler 1.4 " x7 " |
| 34 | HL-6701 | Fitted Digital Sensor Sleeves | Digital Sensor 2" ×9.124" |
| 35 | HL-20963 | Intraoral Camera Sheath | Intraoral Camera 220mm*48mm |
| 36 | HL-21013 | Intraoral Camera Sheath | Intraoral Camera 210*57mm |
| 37 | HL-20855 | Intraoral Camera Sheath | Intraoral Camera 228mm*57mm |
| 38 | HL-20999 | X-ray Sensor Sheath | Digital X-Ray Sensor(Dexis) Compatible TIDI:20999 |
| 225mm*57mm | |||
| 39 | HL-20978 | X-ray Sensor Sheath | Digital X-Ray Sensor(Kodak 6100 Size 1)Compatible |
| TIDI:20978 226mm*57mm | |||
| 40 | HL-20824 | X-ray Sensor Sheath | For SCHICK Size 1 Compatible TIDI:20824 |
| 220mm*47mm | |||
| 41 | HL-20861 | X-ray Sensor Sheath | Digital Sensor 223mm*57mm |
| 42 | HL-20825 | X-ray Sensor Sheath | For SCHICK Size 2 Compatible TIDI:20825 |
| 220mm*57mm | |||
| 43 | HL-20979 | X-ray Sensor Sheath | Digital X-Ray Sensor(Kodak 6100 Size 2) |
| 223mm*56mm | |||
| 44 | HL-20831 | Intraoral Camera Sheath | Intraoral Camera 225mm*55mm |
| 45 | HL-6577A | X-ray Barrier | X-Ray 23" X 31 " |
| 46 | HL-6577B | X-ray Barrier | X-Ray 14" X 13" X 24.5" |
| 47 | HL-100 | Barrier Film | Surface Area That Might Be Touched During |
| Procedure 4"X6" | |||
| 48 | HL-101 | Barrier Film Blue | Surface Area That Might Be Touched During |
| Procedure 4"X6" | |||
| 49 | HL- A Size 0 | X-ray Barrier Envelopes | Phosphor Plates Size 0 Inner: 22×35mm |
| 50 | HL- A Size 1 | X-ray Barrier Envelopes | Phosphor Plates Size 1 Inner:24mmx40mm |
| 51 | HL- A Size 2 | X-ray Barrier Envelopes | Phosphor Plates Size Inner:31mmx41mm |
| 52 | HL- A Size 3 | X-ray Barrier Envelopes | Phosphor Plates Size 3 Inner: 27mmx54mm |
| 53 | HL- A Size 4 | X-ray Barrier Envelopes | Phosphor Plates Size 4 Inner: 57mmx76mm |
| 54 | HL- B Size 0 | X-ray Barrier Envelopes | Phosphor Plates Size 0 Inner: 22×35mm |
| 55 | HL- B Size 1 | X-ray Barrier Envelopes | Phosphor Plates Size 1 Inner:24mmx40mm |
| 56 | HL-B Size 2 | X-ray Barrier Envelopes | Phosphor Plates Size Inner:31mmx41mm |
| 57 | HL-B Size 3 | X-Ray Barrier Envelopes | Phosphor Plates Size 3 Inner: 27mmx54mm |
| 58 | HL-B Size 4 | X-Ray Barrier Envelopes | Phosphor Plates Size 4 Inner: 57mmx76mm |
| 59 | IC-001 | Intraoral Camera Sleeves | Intraoral Camera 1" HEAD X 2" OPENING X |
| 8.25" LENGTH | |||
| 60 | IC-085 | Intraoral Camera Sleeves | Intraoral Camera 0.85" HEAD X 1.75" OPENING X |
| 8.25" LENGTH | |||
| 61 | PS-00/01 | Digital Sensor Cover | Dental Sensor 9"L * 1-3/4"W |
| 62 | PS-002 | Comfort Sensor Sleeves | Dental Sensor 9"L*2"W |
| 63 | PS-5500 | Perforated Bite Block Covers | Bite Block 1"W * 2"L |
| 64 | PS-5501 | Perforated Bite Block Covers | Bite Block 1 1/2"W X 3"L |
| 65 | PS-5502 | Large Digital Sensor Covers | Digital Sensor 2-3/4"W * 8"L |
| 66 | PS-5505 | Universal Digital Sensor | |
| Covers | Digital Sensor 1-1/2"W *7"L | ||
| 67 | PS-5511 | Large Comfort Sensor Covers | Dental Sensor 2"W *4-1/2"L |
| 68 | PS-5522 | Comfort Sensor Covers, #2 | Dental Sensor 1-5/8"W * 4-1/8"L |
| 69 | PS-5533 | Comfort Sensor Covers, #0/#1 | Dental Sensor 1-3/8"W * 4-1/4"L |
| 70 | PS-CYGNUS-1 | Digital Sensor Sleeves | |
| Cygnus#1 | Digital Dental Sensor 24*3.5 | ||
| 71 | PS-DEXIS-U | Digital Sensor Sleeves Dexis | |
| Universal | Digital Dental Sensor 9.5"*1.77" | ||
| 72 | PS308 | Air/Water Syringe Cover | Air Water Syringe 2 ½" X 8 ¼" |
| 73 | PS321 | Air/Water Syringe Cover (¾" | |
| Seal) | Air Water Syringe 2 ½" X10" | ||
| 74 | PS3767-WO | Air/Water Syringe Cover | |
| (Notched) | Air Water Syringe 2 ½" X10" | ||
| 75 | PS4500 | Curing Light Tip Sleeves | Curing Light FOR 7-8mm TIP STICK HOLD |
| 76 | PS4511 | Curing Light Tip Sleeves | Curing Light FOR 11mm TIP STICK HOLD |
| 77 | PS4700 | Cordless Curing Light Cover | Curing Light 1 ¾" X 9 ¾" |
| 78 | PS4701 | Cordless Curing Light Cover | Curing Light 2" X 12 ¾" |
| 79 | PS4707 | Cordless Curing Light Cover | Curing Light 4" X 12 ½" |
| 80 | PS4708 | Cordless Curing Light Cover | Curing Light 3 ¼" X 13" |
| 81 | PS730 | Scaler Sleeves-Stick Hold | Dental Scaler Stick Hold 1-1/2"W*7"L |
| 82 | PS735 | Scaler Sleeves | Dental Scaler 1-⅝" X 8" |
| 83 | XS-6100-0 | Digital Sensor Sheath For | |
| Kodak Size 0 | Digital Sensor 24*3.5 | ||
| 84 | XS-6100-1 | Digital Sensor Sheath For | |
| Kodak Size 1 | Digital Sensor 24*4.3 | ||
| 85 | XS-6100-2 | Digital Sensor Sheath For | |
| Kodak Size 2 | Digital Sensor 24*4.3 | ||
| 86 | XS-CYGNUS-1 | Digital Sensor Sheath For | |
| Cygnus Size 1 | Digital Sensor 24*3.5 | ||
| 87 | XS-DEXIS-2 | Digital Sensor Sheath For | |
| Dexis Size 2 | Digital Sensor 24*3.9 | ||
| 88 | XS-DEXIS-U | Digital Sensor Sheath For | |
| Dexis Universal | Digital Sensor | ||
| 89 | XS-GXDR-1 | Digital Sensor Sheath For | |
| Gendex/Xdr Size 1 | Digital Sensor 24*3.4 | ||
| 90 | XS-GXDR-2 | Digital Sensor Sheath For | |
| Gendex/Xdr Size 2 | Digital Sensor 24*3.9 | ||
| 91 | XS-SHICK-1 | Digital Sensor Sheath For | |
| Schick Size 1 | Digital Sensor 24*3.5 | ||
| 92 | XS-SHICK-2 | Digital Sensor Sheath For | |
| Schick Size 2 | Digital Sensor 24*4.3 | ||
| 93 | SS100 | Single Syringe Sleeves | Single Syringe 210mm51mm0.0275 |
| 94 | SS200 | Automix Syringe Sleeves | Automix Syringe 235mm65mm0.0275 |
| Models for non intra-orally use | |||
| 95 | HL-6567 | T Light Handle Covers | Light Handle For T-Style 4 " L×5-3/4 " W |
| 96 | HL-6568 | Tray Sleeves | Dental Instrument Tray 11-5/8 " ×16 " |
| 97 | HL-6569 | Tray Sleeves | Dental Instrument Tray 10-1/2 " ×14 " |
| 98 | HL-6569S | Tray Sleeves | Dental Instrument Tray 7 1/2 " ×10 1/2 " |
| 99 | HL-6571 | Headrest Covers | Dental Chair Headrest 11"X10" |
| 100 | HL-6572 | Headrest Covers | Dental Chair Headrest 14"X10" |
| 101 | HL-6573-1 | Half Chair Covers | Half Dental Chair 27-1/2 " ×24 " |
| 102 | HL-6573-2 | Half Chair Covers | Half Dental Chair 32 " ×32 " |
| 103 | HL-6574/ | ||
| HL-6576 | Full Chair Covers | Full Dental Chair 29 " ×80 " | |
| 104 | HL-6575 | Full Chair Covers | Wide Full Dental Chair 48 " ×56 " |
| 105 | HL-6583 | T Light Handle Covers | Light Handle Cover 6 " ×2-9/10 " |
| 106 | HL-6587 | Headrest Covers (Roll bag) | Dental Chair Headrest 11.8 " ×9 " |
| 107 | HL-6601 | PC mouse Covers | PC Mouse 6.25 " ×3.5 " |
| 108 | HL-6702 | Keyboard Covers | Keyboard 22"X13.78" |
| 109 | HL-6568-2 | Tray Barriers | Dental Instrument Tray 11-5/8" X 14" Size A |
| 110 | HL-6569-2 | Tray Barriers | Dental Instrument Tray 11.5" X 16" Size E |
| 111 | HL-7510 | Tray Barriers | Dental Instrument Tray 7.5" X 10.5" Size F |
| 112 | HL-7521 | Keyboard Cover | Keyboard 22" X 14" |
| 113 | PS101 | Small Half Chair Cover | Dental Chair 20''W X 30''L |
| 114 | PS105 | Full Chair Cover | Dental Chair 33''W X 54''L |
| 115 | PS203 | Size E Tray Cover W/Lock | |
| Top | Plastice/Metal Trays 11-1/2"*16" | ||
| 116 | PS328T | T-Shape Lite Handle Cover | T-Shape Lite Handle 6"W X 3"L |
| 117 | PS408 | Wireless Keyboard Covers | Keyboard 24"Lx 10"W |
| 118 | PS410-STWD | Wide Lcd Cover | Monitor And Keyboard 25"WX16"L W/3" POCKET |
| 119 | PS410-WD | Wide Lcd+Keyboard Cover | Monitor And Keyboard 25"W*26"Lw/3"POCKET |
| 120 | PS670 | Chair Armrest Covers | Chair Armrest 24"Lx6"W |
| 121 | PS680 | Jumbo Headrest Cover | Chair Headrest 14 1/2"L X 14 3/4"W |
7
Intersection Of Ronghua Road And Siwei Street, Yongqing Industrial Area, Langfang City,065600,Hebei, China
8
Intersection Of Ronghua Road And Siwei Street, Yongqing Industrial Area, Langfang City,065600,Hebei, China
9
Intersection Of Ronghua Road And Siwei Street, Yongqing Industrial Area, Langfang City,065600,Hebei, China
F. Comparison with predicate device
| Device | Subject Device | Predicate Device | Comment |
|---|---|---|---|
| Manufacturer | Yongqing Huaguan Dental | ||
| Instruments Factory | BH Medical Products Co., Ltd.. | / | |
| 510K number | K233918 | K190484 | / |
| Product Name | Dental Barrier and Sleeves | BH Medical Dental Barrier Sleeves | |
| and Barrier Film | / | ||
| Classification | Class II Device (21 CFR 878.4370) | Class II Device (21 CFR 878.4370) | Same |
| Intended use | Dental Barrier and Sleeves are | ||
| intended to be used as a disposable | |||
| barrier for dental instruments and | |||
| equipment. This device is non-sterile | |||
| and intended for single patient use | |||
| only | BH Medical Dental Barrier Sleeves | ||
| and Barrier Film are intended to be | |||
| used as a disposable barrier for dental | |||
| instruments and equipment. This | |||
| device is non-sterile and intended for | |||
| single patient use only. | Same | ||
| Device | |||
| Description | Dental Barrier and Sleeves consist of | ||
| various sizes and shapes of | |||
| polyethylene covers which are | |||
| positioned on various small hand-held | |||
| dental instruments such as hand | |||
| pieces, 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. | BH Medical Dental Barrier Sleeves | ||
| and Barrier Film consist of various | |||
| sizes and shapes of clear polyethylene | |||
| covers which are positioned on | |||
| various small hand-held dental | |||
| instruments such as hand pieces, | |||
| 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. | Same | ||
| Classification | |||
| Product Code | PEM | PEM | Same |
| Material | Polyethylene film | Polyethylene film | Same |
| Material | |||
| Composition | LLDPE(80%),LDPE(20%) | LLDPE(80%),LDPE(20%),Blue | |
| pigment(#992482),Adhesive(#992 | |||
| 482,#992483) | Same | ||
| Specifications | |||
| and Tolerances | Paper Backing: Some of the model; | ||
| Film Thickness: 0.02-0.06mm | |||
| Tolerance: |