Intraoral, Dental Foam Protector

Which Manufacturers in China Make This?

One manufacturer in China holds an FDA registration for this device type, based in Zhejiang.

Ningbo Cooskin Stationery Co., Ltd. Zhejiang

What Is This Device?

Intended to provide a soft barrier between wired mouth hardware and oral mucosa.

How Is PFL Classified?

Intraoral, Dental Foam Protector is FDA product code PFL, Class 1, 21 CFR 872.6890.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

Intraoral, Dental Foam Protector

Reliabite Chewie Aligner Seater Y-Shaped Firm

3 catalogue numbers from RBYFM, listed by Reliance Orthodontic Products, Inc., United States, under Intraoral, Dental Foam Protector. 1 manufacturer in China is registered for this product code.

Intraoral, Dental Foam Protector

Reliabite Chewie Aligner Seater Roll

Reliabite Chewie Aligner Seater Roll: 4 catalogue numbers listed by Reliance Orthodontic Products, Inc., United States, under Intraoral, Dental Foam Protector. 1 manufacturer in China is registered for this product code.

Intraoral, Dental Foam Protector

Reliabite Chewie Aligner Seater Y-Shaped Soft

3 catalogue numbers from RBYSA, listed by Reliance Orthodontic Products, Inc., United States, under Intraoral, Dental Foam Protector. 1 manufacturer in China is registered for this product code.

Intraoral, Dental Foam Protector

Which Manufacturers in China Make This?

What Is This Device?

How Is PFL Classified?

How Does It Reach the US Market?

Reliabite Chewie Aligner Seater Y-Shaped Firm

Reliabite Chewie Aligner Seater Roll

Reliabite Chewie Aligner Seater Y-Shaped Soft

Where China Actually Supplies