FDA.report

Spring

Primary DI
D78869371000000
Brand
Spring
Company
Gc Orthodontics America Inc.
Model
69-3710-0000
Catalog number
69-3710-0000
Device description
NEET NITI SPRINGS 018 SM PK25
Published
2022-11-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
ECOSPRING, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
ECOSpring, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D78869371000001PrimaryHIBCC0
D78869371000000Unit of UseHIBCC0

GMDN Terms

TermDefinition
Orthodontic springA dental device in the shape of a coil intended to be placed around an archwire, a rod, in a bracket, on hooks, pins, and/or between teeth, to apply force (e.g., rotational, uprighting, horizontal) as part of an orthodontic force-producing appliance system. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(708)897-8859GCOAInfo@gcorthodontics.com

Regulatory Flags

DUNS number
063167128
Device count
25
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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D78812202AA519151EXPERIENCE12/20-2AA5-191512/20-2AA5-19152023-03-30
D788122C0500101EXPERIENCE12-2C05-001012-2C05-00102023-03-30
D788151CC5S0101CHIC15-1CC5-S01015-1CC5-S0102023-03-30
D788152CC5S0101CHIC15-2CC5-S01015-2CC5-S0102023-03-30
D788312BB5GP201LEGEND31-2BB5-GP2031-2BB5-GP202023-03-30
D788312CC542191LEGEND31-2CC5-421931-2CC5-42192023-03-30
D788312CC579391LEGEND31-2CC5-793931-2CC5-79392023-03-30
D78855016001550Rodney55-0160-015555-0160-01552023-03-30
D78892500100001MULTI FA92-5001-000092-5001-00002023-03-30
D78892500200001MULTI FA92-5002-000092-5002-00002023-03-30
D78892500300001MULTI FA92-5003-000092-5003-00002023-03-30
D78892500400001MULTI FA92-5004-000092-5004-00002023-03-30
D78892500500001MULTI FA92-5005-000092-5005-00002023-03-30
D78855016000010Chewies55-0160-000155-0160-00012023-01-25
D78855016000020Chewies55-0160-000255-0160-00022023-01-25
D78855016000030Chewies55-0160-000355-0160-00032023-01-25
D78855016000040Chewies55-0160-000455-0160-00042023-01-25
D78811202AA525611EXPERIENCE11/20-2AA5-256111/20-2AA5-25612023-03-14

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