AccessGUDID - DEVICE: SciPharm Gel Etch Dental Conditioner (D801SP7012B1)

GUDID

Device Identifier (DI) Information

Brand Name: SciPharm Gel Etch Dental Conditioner
Version or Model: SP 70-12 B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 70-12
Company Name: SCIENTIFIC PHARMACEUTICALS, INC.

Primary DI Number: D801SP7012B1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 096010525 *Terms of Use

Device Description: Gel Etch is a High Viscosity Enamel Etching Agent for All Bonding Purposes. 12 grams Green Gel Etch Syringe. Boxed.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36153	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBF	Material, Tooth Shade, Resin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K872569	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 83 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e3225d65-180a-4f8b-9ac1-0fbc104a731c
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 10, 2016