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Blue Series, Retainer

FDA UDI

Class II (US FDA UDI)

by Modern Dental Laboratory (DG) Co., Ltd.

Identity

Trade Name
Blue Series,Retainer FDA UDI
Generic Name
Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
Model / Reference
170 FDA UDI

Identifiers

Primary DI / UDI-DI
06972677871709 FDA UDI
FDA Product Code
LRK FDA UDI
DYT FDA UDI
GMDN Term
Mandible-repositioning sleep-disordered breathing orthosis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.5570 FDA UDI
872.5525 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

No

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthodontic retainerMandible-repositioning sleep-disordered breathing orthosis

Blue Series, Retainer by Modern Dental Laboratory (DG) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mandible-repositioning sleep-disordered breathing orthosis.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Modern Dental Laboratory (DG) Co., Ltd.

Sources (1)

  • FDA UDI 7ef64ecd-2ea1-4c6c-8c4d-d975f13ba3ad 32 fields · synced Jun 8, 2026