DEVICE: SciPharm Gel Etch Dental Conditioner (D801SP70125SB1)

Device Identifier (DI) Information

SciPharm Gel Etch Dental Conditioner
SP 70-125 SB
In Commercial Distribution
70-125
SCIENTIFIC PHARMACEUTICALS, INC.
D801SP70125SB1
HIBCC

1
096010525 *Terms of Use
Gel Etch is a High Viscosity Enamel Etching Agent for All Bonding Purposes. 60 gram Green Gel Etch Refill Syringe. Boxed. Spanish
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Dental etching solution An acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. After application, this device cannot be reused.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
EBF Material, Tooth Shade, Resin
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 15 and 83 Degrees Fahrenheit
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

dc3f6282-0d64-491d-b3d6-baab87ded690
March 29, 2018
2
August 11, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
800-634-3047
Denise@scipharm.com
909-595-9922
Denise@scipharm.com
CLOSE