Phase Ortho

GUDID 00860002302355

Clear sequential aligner / progressive orthodontic appliance system.

DERBY DENTAL LABORATORY, INC

Orthodontic appliance system, progressive Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner
Primary Device ID00860002302355
NIH Device Record Keyef27930a-4484-4a03-a01f-9962d45ff200
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhase Ortho
Version Model NumberPOCA
Company DUNS603741349
Company NameDERBY DENTAL LABORATORY, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860002302355 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NXCAligner, Sequential

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-11
Device Publish Date2020-05-01

On-Brand Devices [Phase Ortho]

00860002302362Clear sequential aligner (final retainer) / progressive orthodontic appliance system.
00860002302355Clear sequential aligner / progressive orthodontic appliance system.

Trademark Results [Phase Ortho]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PHASE ORTHO
PHASE ORTHO
88752616 not registered Live/Pending
Derby Dental Laboratory, Inc.
2020-01-09

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