BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

RIVA PROTECT

DI: DO3686850001 · Model: RIVA PROTECT PINK 50 CAP FAST · SDI LIMITED

View on AccessGUDID

Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

50

Let the assistant research this device

The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Brand Name: RIVA PROTECT
Primary DI: DO3686850001
Version / Model: RIVA PROTECT PINK 50 CAP FAST
Catalog Number: 8685000
Company Name: SDI LIMITED
Labeler DUNS: 753221852
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 50
Record Status: Published
Publish Date: 2016-10-07
Public Version: 4
Public Version Date: 2025-01-10
Public Version Status: Update
Public Device Record Key: 0094c355-fbab-46e7-a740-1aed6c1edb70
Distribution End Date: 2025-01-09

Device Characteristics

Single Use: Yes
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: Yes
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EBC	SEALANT, PIT AND FISSURE, AND CONDITIONER	Dental	872.3765	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16704	Glass ionomer dental cement	A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	DO3686850001	HIBCC
Unit of Use	DO3686850000	HIBCC

Customer Contacts

Phone: +18002285166
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K050871	000

Storage Conditions

Type: Handling Environment Atmospheric Pressure
Temperature Range: 5 – 25 Degrees Celsius