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Parkell® SDS-837-012M

by Parkell, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number10810000527783 UDI-DI Date26 Jul 2019ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Parkell®
Generic name
Diamond dental bur, single-use
Model / Ref / Catalog
SDS-837-012M
Primary DI / UDI-DI
10810000527783
FDA product code
DZP
GMDN term
Diamond dental bur, single-use
Device class
Class I
Regulation number
872.4535
GUDID distribution status
In Commercial Distribution
Size
Length — 8.0 Millimeter
Outer Diameter — 1.2 Millimeter

Related devices

Category: Diamond dental bur, single-use

Other devices from Parkell, Inc.

See all devices from Parkell, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date

Other properties (9)

  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Serial number: No
  • Manufacturing date: No