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SciPharm Activated Porcelain Conditioner, Non-Boxed

FDA UDI

Class II (US FDA UDI)

by Scientific Pharmaceuticals, Inc.

Identity

Trade Name
SciPharm Activated Porcelain Conditioner, Non-Boxed FDA UDI
Generic Name
Orthodontic bracket adhesive FDA UDI
Device Name
Material used for the Preparation of Surfaces Prior to Bonding or Cementing. FDA UDI
Model / Reference
SP 50-064 N FDA UDI
Description
Material used for the Preparation of Surfaces Prior to Bonding or Cementing. FDA UDI

Identifiers

Catalog Number
50-064 FDA UDI
Primary DI / UDI-DI
D801SP50064N1 FDA UDI
510(k) Number
K833810 FDA UDI
FDA Product Code
EBF FDA UDI
GMDN Term
Orthodontic bracket adhesive FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3690 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orthodontic bracket adhesive

SciPharm Activated Porcelain Conditioner, Non-Boxed by Scientific Pharmaceuticals, Inc. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Orthodontic bracket adhesive.

Cleared under the same submission

K833810 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Scientific Pharmaceuticals, Inc.

Sources (1)

  • FDA UDI 6c573bdc-8692-4df9-afb5-21e35025c934 37 fields · synced May 30, 2026