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Rolence CU-100A

by Rolence Enterprise Co., Ltd.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04713909450451 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Rolence
Generic Name
Dental/surgical polymerization lamp
Model / Reference
CU-100A
Primary DI / UDI-DI
04713909450451
510(k) Number
FDA Product Code
EBZ
GMDN Term
Dental/surgical polymerization lamp
Device Class
Class II
Regulation Number
872.6070
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K001719)

Show all (9)

Other devices from Rolence Enterprise Co., Ltd.

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Properties

  • Serial Number

Other properties (13)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No