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Sterling Ben-4HG-O-Nk

by J.morita Mfg.corp.

Listed FDA GUDID listing, no authorization on record

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 Number04548213060177 UDI-DI Date20 Feb 2026ListedStatusListed GUDID: 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  • Withdrawn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
Sterling
Generic Name
Dental surgical power tool motorized handpiece/set, pneumatic
Model / Reference
BEN-4HG-O-NK
Primary DI / UDI-DI
04548213060177
510(k) Number
FDA Product Code
EFA
GMDN Term
Dental surgical power tool motorized handpiece/set, pneumatic
Device Class
Class I
Regulation Number
872.4200
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K061701)

Show all (12)

Other devices from J.morita Mfg.corp.

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Properties

  • Single Use
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (10)

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