Regisil® Vinyl Polysiloxane Bite Impression Material 619130

GUDID D002619130102

Regisil® VPS Bite Reg Material (Purple), Standard Package

DENTSPLY INTERNATIONAL INC.

Silicone dental impression material
Primary Device IDD002619130102
NIH Device Record Key9ee39b5b-7bad-4386-9cee-624029afb50e
Commercial Distribution Discontinuation2018-11-10
Commercial Distribution StatusNot in Commercial Distribution
Brand NameRegisil® Vinyl Polysiloxane Bite Impression Material
Version Model Number619130
Catalog Number619130
Company DUNS083235549
Company NameDENTSPLY INTERNATIONAL INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com

Device Dimensions

Total Volume90 Milliliter
Device Size Text, specify0
Total Volume90 Milliliter
Device Size Text, specify0
Total Volume90 Milliliter
Device Size Text, specify0
Total Volume90 Milliliter
Device Size Text, specify0
Total Volume90 Milliliter
Device Size Text, specify0
Total Volume90 Milliliter
Device Size Text, specify0
Total Volume90 Milliliter
Device Size Text, specify0
Total Volume90 Milliliter
Device Size Text, specify0
Total Volume90 Milliliter
Device Size Text, specify0
Total Volume90 Milliliter
Device Size Text, specify0
Total Volume90 Milliliter
Device Size Text, specify0
Total Volume90 Milliliter
Device Size Text, specify0
Total Volume90 Milliliter
Device Size Text, specify0
Total Volume90 Milliliter
Device Size Text, specify0
Total Volume90 Milliliter
Device Size Text, specify0
Total Volume90 Milliliter
Device Size Text, specify0
Total Volume90 Milliliter
Device Size Text, specify0
Total Volume90 Milliliter
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight.

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD0026191300 [Primary]
HIBCCD002619130102 [Package]
Contains: D0026191300
Package: Box [10 Units]
Discontinued: 2018-11-08
Not in Commercial Distribution

FDA Product Code

ELWMATERIAL, IMPRESSION

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2024-01-30
Device Publish Date2016-09-21

Devices Manufactured by DENTSPLY INTERNATIONAL INC.

D0013011311 - Ceramco® 32026-02-17
D0013011321 - Ceramco® 32026-02-17
D0013011351 - Ceramco® 32026-02-17
D0013011361 - Ceramco® 32026-02-17
D0013011381 - Ceramco® 32026-02-17
D0013011401 - Ceramco® 32026-02-17
D0013011411 - Ceramco® 32026-02-17
D0013011421 - Ceramco® 32026-02-17

Trademark Results [Regisil]

Mark Image

Registration | Serial
Company
Trademark
Application Date
REGISIL
REGISIL
73433028 1284061 Live/Registered
Dentsply International Inc.
1983-07-01
REGISIL
REGISIL
72306692 0874108 Live/Registered
REGIS CHEMICAL COMPANY
1968-09-05
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.