FDA.reportPublic FDA data

Dental impression spacer

Definition
A device comprised of thin layers of wax or other plastic materials intended to be applied to the surface of edentulous ridges and dental structures before the preliminary application of impression material. After producing the preliminary model, the device is discarded, thus providing an equidistant space between the oral structures and the impression tray that allows escape of excess impression material and entrapped air, and facilitates manipulation during final impression taking. This is a single-use device.
GUDID devices
63
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00842092105375HaderPreat Corporation01017032022-09-22
00893202000936LOCATOR®Zest Anchors, LLC08569-202022-03-26
10386040002677CHECK-BITE™Gc America Inc.2620252022-07-11
10386040009478GC OCCLUSAL MATRIX SYSTEMGc America Inc.4391542022-07-13
00842092186596PreatPreat Corporation7100019-102025-09-05
00842092186602PreatPreat Corporation7100020-42025-09-05
00842092186619PreatPreat Corporation7100020-202025-09-05
D785LOKPD40OCO LOK BLOCK OUT SPACEROCO BIOMEDICAL INCOCO LOK BLOCK OUT SPACER2024-03-12
00840481134968LOCATOR, compatible with Implant DirectZest Anchors, LLC085142023-12-22
00841549118197Blockout Spacers (10) STERNGOLD DENTAL LLC9090132023-10-05
00841549118470MOR® Blockout Shim (25) STERNGOLD DENTAL LLC9090172023-10-05
00841549118371Stern Root Anchor Laboratory Spacers, 5STERNGOLD DENTAL LLC8331702023-10-04
00842092155349HaderPREAT CORPORATION01017032022-09-22
00386040009471GC OCCLUSAL MATRIX SYSTEMGc America Inc.4391542022-07-13
00386040002670CHECK-BITE™Gc America Inc.2620252022-07-11
00840481127427LOCATORZest Anchors, LLC09260-22022-07-08
00840481127434LOCATORZest Anchors, LLC09260-42022-07-08
00840481127441LOCATORZest Anchors, LLC09260-102022-07-08
00840481119644LOCATOR F-TxZest Anchors, LLC10043-012022-07-07
10386040006330COE TRAY PLASTIC™Gc America Inc.2400112022-07-07
10386040006347COE TRAY PLASTIC™Gc America Inc.2400122022-07-07
10386040006354COE TRAY PLASTIC™Gc America Inc.2400132022-07-07
10386040006361COE TRAY PLASTIC™Gc America Inc.2400142022-07-07
10386040006378COE TRAY PLASTIC™Gc America Inc.2400162022-07-07
10386040006385COE TRAY PLASTIC™Gc America Inc.2400912022-07-07
10386040006392COE TRAY PLASTIC™Gc America Inc.2400922022-07-07
10386040006408COE TRAY PLASTIC™Gc America Inc.2400932022-07-07
10386040006422COE TRAY PLASTIC™Gc America Inc.2401112022-07-07
10386040006439COE TRAY PLASTIC™Gc America Inc.2401132022-07-07
10386040006446COE TRAY PLASTIC™Gc America Inc.2401912022-07-07
10386040006453COE TRAY PLASTIC™Gc America Inc.2401922022-07-07
10386040006460COE TRAY PLASTIC™Gc America Inc.2401932022-07-07
00840481110078LOCATOR R-TxZest Anchors, LLC30017-012022-07-06
00840481110085LOCATOR R-TxZest Anchors, LLC30018-012022-07-06
00840481122149LOCATOR R-TxZest Anchors, LLC30060-01-102022-07-06
00840481131882LOCATOR, Dentsply Sirona SystemZest Anchors, LLC30017-012022-07-06
00840481131899LOCATOR, Dentsply Sirona SystemZest Anchors, LLC30018-012022-07-06
00840481127267LOCATOR, compatible with Ankylos SystemZest Anchors, LLC085142022-07-01
00840481127298LOCATOR, compatible with Ankylos SystemZest Anchors, LLC085692022-07-01
00840481131851LOCATOR, Dentsply Sirona SystemZest Anchors, LLC085142022-07-01
00840481127625LOCATOR®Zest Anchors, LLC085142022-03-26
00840481132803LOCATOR®Zest Anchors, LLC08569-202022-03-26
00893202000929LOCATOR®Zest Anchors, LLC085692022-03-26
04710986432530ZiboneCOHO BIOMEDICAL TECHNOLOGY CO., LTD.SP-36102020-03-11
07640166511809SFI-BarCendres+Métaux SA0520822019-03-14
10841396102056Putty SpacerKERR CORPORATION095262016-08-31
D6582400111COE TRAY PLASTIC™Gc America Inc.2400112017-02-10
D6582400121COE TRAY PLASTIC™Gc America Inc.2400122017-02-10
D6582400131COE TRAY PLASTIC™Gc America Inc.2400132017-02-10
D6582400141COE TRAY PLASTIC™Gc America Inc.2400142017-02-10
D6582400161COE TRAY PLASTIC™Gc America Inc.2400162017-02-10
D6582400911COE TRAY PLASTIC™Gc America Inc.2400912017-02-10
D6582400921COE TRAY PLASTIC™Gc America Inc.2400922017-02-10
D6582400931COE TRAY PLASTIC™Gc America Inc.2400932017-02-10
D6582400941COE TRAY PLASTIC™Gc America Inc.2400942017-02-10
D6582401111COE TRAY PLASTIC™Gc America Inc.2401112017-02-10
D6582401131COE TRAY PLASTIC™Gc America Inc.2401132017-02-10
D6582401911COE TRAY PLASTIC™Gc America Inc.2401912017-02-10
D6582401921COE TRAY PLASTIC™Gc America Inc.2401922017-02-10
D6582401931COE TRAY PLASTIC™Gc America Inc.2401932017-02-10
D6582401941COE TRAY PLASTIC™Gc America Inc.2401942017-02-10
D6582620251CHECK-BITE™Gc America Inc.2620252016-08-01
D6584391541GC OCCLUSAL MATRIX SYSTEMGc America Inc.4391542017-02-10