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Monolith Etching-Gel-Tips M526

by Prisman Inc.

Monolith Etching-Gel-Tips M526 is a Class I device made by Prisman Inc., listed in FDA GUDID since 2 Nov 2021 (UDI-DI 04064896000533), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04064896000533 UDI-DI Date2 Nov 2021ListedStatusListed 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  • Withdrawn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
Monolith Etching-Gel-Tips
Generic name
Dental material injection cannula, single-use
Model / reference
M526
Primary DI / UDI-DI
04064896000533
FDA product code
JEW
GMDN term
Dental material injection cannula, single-use
Device class
Class I
Regulation number
872.6650
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental material injection cannula, single-use

Similar devices in this category

Other devices filed under Dental material injection cannula, single-use.

Other devices from Prisman Inc.

See all devices from Prisman Inc. →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)