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Vector R&D, Inc 10-HE-S

by Vector R&D, Inc.

Vector R&D, Inc 10-HE-S is a Class II device made by Vector R&D, Inc., cleared under FDA 510(k) K040396 on 22 Apr 2004 and listed in FDA GUDID since 7 Feb 2023 (UDI-DI 00810113691053), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K040396

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810113691053 UDI-DI Date7 Feb 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK040396 Date22 Apr 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K040396 decided 22 Apr 2004 Active
  • FDA GUDID UDI-DI 00810113691053 listed 7 Feb 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K040396
  2. Listed FDA GUDID 00810113691053

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Vector R&D, Inc
Generic name
Dental surgical power tool motorized handpiece/set, electric
Model / Ref / Catalog
10-HE-S
Description
Piezo Technologies Autoclavable Replacement Handpiece Only - Satelec* Type
Primary DI / UDI-DI
00810113691053
510(k) Number
FDA product code
ELC
GMDN term
Dental surgical power tool motorized handpiece/set, electric
Device class
Class II
Regulation number
872.4850
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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Properties

  • Serial number
Other properties (14, all answered No)