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REGENX PuraCAL PGCS05

by Ace Surgical Supply Co., Inc.

REGENX PuraCAL PGCS05 is a Class II device made by Ace Surgical Supply Co., Inc., listed in FDA GUDID since 15 Dec 2016 (UDI-DI 00614950008681), 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 Number00614950008681 UDI-DI Date15 Dec 2016ListedStatusListed 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  • Withdrawn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
REGENX PuraCAL
Generic name
Dental root surface conditioner
Model / Ref / Catalog
PGCS05
Primary DI / UDI-DI
00614950008681
FDA product code
LYC
GMDN term
Dental root surface conditioner
Device class
Class II
Regulation number
872.3930
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental root surface conditioner

Other devices from Ace Surgical Supply Co., Inc.

See all devices from Ace Surgical Supply Co., Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)