← Back to catalogue

Cocoon

FDA UDI

Class II (US FDA UDI)

by Dexcowin Co., Ltd.

Identity

Trade Name
Cocoon FDA UDI
Generic Name
Hand-held intraoral dental x-ray system, digital FDA UDI
Device Name
Portable x-ray system indicated for taking diagnostic dental x-rays for both pediatric and adult patients using intraoral film or PSP or digital sensors. FDA UDI
Model / Reference
DX-7017 FDA UDI
Description
Portable x-ray system indicated for taking diagnostic dental x-rays for both pediatric and adult patients using intraoral film or PSP or digital sensors. FDA UDI

Identifiers

Primary DI / UDI-DI
08800000500058 FDA UDI
FDA Product Code
MUH FDA UDI
GMDN Term
Hand-held intraoral dental x-ray system, digital FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.1800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Hand-held intraoral dental x-ray system, digital

Cocoon by Dexcowin Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hand-held intraoral dental x-ray system, digital.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Dexcowin Co., Ltd.

Sources (1)

  • FDA UDI d2a5ccd1-27b4-4bb3-8386-bb565d9738d1 35 fields · synced May 30, 2026