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Interface White 7101

by Temrex Corp.

Interface White 7101 is a Class II device made by Temrex Corp., cleared under FDA 510(k) K897130 on 27 Mar 1990 and listed in FDA GUDID since 28 Jan 2020 (UDI-DI 00850015110115), active as of 23 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 23 Oct 2026

Documents

510(k) K897130

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850015110115 UDI-DI Date28 Jan 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK897130 Date27 Mar 1990DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K897130 decided 27 Mar 1990 Active
  • FDA GUDID UDI-DI 00850015110115 listed 28 Jan 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K897130
  2. Listed FDA GUDID 00850015110115

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Interface White
Generic name
Dental acrylic resin
Model / reference
7101
Primary DI / UDI-DI
00850015110115
510(k) Number
FDA product code
EJK
GMDN term
Dental acrylic resin
Device class
Class II
Regulation number
872.3250
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code EJK (Liner, Cavity, Calcium Hydroxide).

Other devices from Temrex Corp.

See all devices from Temrex Corp. →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)