Dental Barriers and Sleeves

Who Makes This Device Type in China?

12 manufacturers in China hold an FDA registration for this device type, concentrated in Guangdong, Jiangsu and Hebei, and 2 other provinces. 2 of them are contract manufacturers, able to build to a buyer’s own specification.

BH Medical Products Co., Ltd. Jiangsu, contract manufacturer
Dongguan Wanjin Industrial Co., Ltd. Guangdong
Fomed Industries Inc Hubei, contract manufacturer
Hubei Guarddent Medical Technology Co., Ltd. Hubei
Jinyuan Medical Equipment(Tianjin)Co., Ltd. Tianjin, contract manufacturer
Premium Plus (Dongguan) Limited Guangdong
Suzhou Pac-Dent Technology Co., Ltd. Jiangsu, contract manufacturer
Tianjin Water Source Tech Co., Ltd. Tianjin
Wellmed Dental Medical Supply Co., Ltd. Guangdong
Yueying Medical Instruments (Langfang) Co., Ltd. Hebei, contract manufacturer
Yongqing Huaguan Dental Instruments Factory Hebei, contract manufacturer
iBrite Suzhou Technology Co., Ltd. Jiangsu, contract manufacturer

What Is It?

Intended to serve as a disposable barrier for dental instruments to reduce the risk of cross contamination between dental patients.

What Is FDA Product Code PEM?

Dental Barriers And Sleeves is FDA product code PEM, Class 2, 21 CFR 878.4370.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 7 clearances under this code; the FDA took a median of 91 days from receipt to decision on them.

Dental Barriers And Sleeves

EAR Holder Covers

Catalogue number 208224, listed by Palodex Group OY, Finland, under Dental Barriers And Sleeves. 12 manufacturers in China are registered for this product code.

Dental Barriers And Sleeves

Top Quality Manufacturing Half Chair Sleeves

Half Chair Sleeves (Roll) Disposable Clear Plastic Tear-Resistant Easy to Use Dispenser Box

Dental Barriers And Sleeves

OdneClean

OdneClean barrier sleeves, 100pcs per box.

Dental Barriers And Sleeves

Ear Holder Disposable Cover

Catalogue number 900638-DEX, listed by Palodex Group OY, Finland, under Dental Barriers And Sleeves. 12 manufacturers in China are registered for this product code.

Dental Barriers And Sleeves

Nasion Support Disposable Cover

Catalogue number 900511-DEX, listed by Palodex Group OY, Finland, under Dental Barriers And Sleeves. 12 manufacturers in China are registered for this product code.

Dental Barriers And Sleeves

Digora BAG Size 3 200 PCS

Catalogue number 901143, listed by Palodex Group OY, Finland, under Dental Barriers And Sleeves. 12 manufacturers in China are registered for this product code.

Dental Barriers And Sleeves

Barrier Sleeve

Barrier Sleeves, i2, Isodry, i3

Dental Barriers And Sleeves

Optibag Size 0 200PCS

Catalogue number 900183-PTU, listed by Palodex Group OY, Finland, under Dental Barriers And Sleeves. 12 manufacturers in China are registered for this product code.

Dental Barriers And Sleeves

Valo Grand

VALO GRAND Barrier Sleeve

Dental Barriers And Sleeves

QUIKsheath Barriers Scaler/Instrument

cut contamination and clean-up time between patients for only pennies per sheath. Unique pre-punched design pulls over instruments and scalers more easily for an effective barrier. Ideal…

Dental Barriers And Sleeves

EAR ROD Cover Disposable CC3

Catalogue number 6801150-SDX, listed by Palodex Group OY, Finland, under Dental Barriers And Sleeves. 12 manufacturers in China are registered for this product code.

Dental Barriers And Sleeves

LIP Support Disposable Cover

2 catalogue numbers from 6801130, listed by Palodex Group OY, Finland, under Dental Barriers And Sleeves. 12 manufacturers in China are registered for this product code.

Dental Barriers And Sleeves

StarDental Instrument Solutions

Disposable Plastic Barrier PKGD 100 BOX Identafi Wand

Dental Barriers And Sleeves

QUIKsheath Barriers Small Digital X-Ray Sensor

eliminate the damaging effects of disinfectants on costly digital X-ray sensors. Clear plastic construction aids visibility. 8" long. 500 sheaths per box. Fits sensors up to 1-3/8" wide.

Dental Barriers And Sleeves

Burkhart Tray Sleeve a 11 5/8 X 14 1/2 (500)

Catalogue number 72720838, listed by Burkhart Dental Supply Co., THE, under Dental Barriers And Sleeves. 12 manufacturers in China are registered for this product code.

Dental Barriers And Sleeves

Scott’s Syringe Sleeve 2.5″X10″ (500) Clear

SYRINGE SLEEVE (500/box) Dimensions: 2-1/2" x 10", Color: Clear; For more information:

Dental Barriers And Sleeves

QUIKsheath Barriers Low-Speed Straight

educe contamination and cleanup time between patients for only pennies per sheath. Unique pre-punched design pulls over handpieces more easily for an effective barrier. Provides visual…

Dental Barriers And Sleeves

Digora BAG Size 1 200 PCS

Catalogue number 901141, listed by Palodex Group OY, Finland, under Dental Barriers And Sleeves. 12 manufacturers in China are registered for this product code.

Dental Barriers And Sleeves

Hygiene BAG Size 0 200 PCS

Catalogue number 900475-DEX, listed by Palodex Group OY, Finland, under Dental Barriers And Sleeves. 12 manufacturers in China are registered for this product code.

Dental Barriers And Sleeves

Light Handle Sleeve

Catalogue number 670350, listed by Young Dental Manufacturing I, LLC, under Dental Barriers And Sleeves. 12 manufacturers in China are registered for this product code.

Dental Barriers And Sleeves

VisCalor Dispenser

Preheating dispenser for composite Caps - protective cover

Dental Barriers And Sleeves

Acclean

Catalogue number 5703906, listed by Henry Schein, Inc., United States, under Dental Barriers And Sleeves. 12 manufacturers in China are registered for this product code.

Dental Barriers And Sleeves

Hygiene BAG FL Size 3 200 PCS

Catalogue number 900374-DEX, listed by Palodex Group OY, Finland, under Dental Barriers And Sleeves. 12 manufacturers in China are registered for this product code.

Dental Barriers And Sleeves

Digora BAG Size 2 200 PCS

Catalogue number 901142, listed by Palodex Group OY, Finland, under Dental Barriers And Sleeves. 12 manufacturers in China are registered for this product code.

Dental Barriers And Sleeves

Burkhart Tray Sleeve Size F 11-1/2 X 10-1/2 (500)

Catalogue number 72720837, listed by Burkhart Dental Supply Co., THE, under Dental Barriers And Sleeves. 12 manufacturers in China are registered for this product code.

Dental Barriers And Sleeves

Safco SafeWrap Basics Syringe Sleeves

Safco SafeWrap Basics syringe sleeves, clear, 500/box

Dental Barriers And Sleeves

ScanX Barrier Envelope, 300 Pcs, Size 2

Light protection covers for image plates (used with the ScanX image plate scanners).

Dental Barriers And Sleeves

Comfort Occlusal Hygiene Bags for Occlusal Projection Images, Size 4c, 100 PCS

Catalogue number 900606, listed by Palodex Group OY, Finland, under Dental Barriers And Sleeves. 12 manufacturers in China are registered for this product code.

Dental Barriers And Sleeves

Ultrapro TX Cordless

Ultrapro Tx Cordless Prophy Motor Barrier Sleeves 500 ct

Dental Barriers And Sleeves

Defend

Air/Water Syringe Sleeves 2.5 inch x 10 inch Clear

Dental Barriers And Sleeves

Optibag Size 3 200PCS

Catalogue number 900186-PTU, listed by Palodex Group OY, Finland, under Dental Barriers And Sleeves. 12 manufacturers in China are registered for this product code.

Dental Barriers And Sleeves

Safco SafeWrap Curing Light Sleeves

Safco SafeWrap curing light sleeves 250/box

Dental Barriers And Sleeves

Hygiene BAG FL Size 0 200 PCS

Catalogue number 900359-DEX, listed by Palodex Group OY, Finland, under Dental Barriers And Sleeves. 12 manufacturers in China are registered for this product code.

Dental Barriers And Sleeves

Digora BAG Size 0 200 PCS

Catalogue number 901140, listed by Palodex Group OY, Finland, under Dental Barriers And Sleeves. 12 manufacturers in China are registered for this product code.

Dental Barriers And Sleeves

Optibag Size 1 200PCS

Catalogue number 900184-PTU, listed by Palodex Group OY, Finland, under Dental Barriers And Sleeves. 12 manufacturers in China are registered for this product code.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer