FDA.report

ERA® Micro DO SP Basic Kit w/ Tools SS

Primary DI
00841549101830
Brand
ERA® Micro DO SP Basic Kit w/ Tools SS
Company
STERNGOLD DENTAL LLC
Model
811413
Device description
Resilient precision attachment. Kit Contains: Three Micro small post females, (2-0°& 1-11°) Males, 3 sets of 5,(two each of white and black and one orange), 2 metal jackets, 2 Alignment handles,2 blockout spacers, 1 of each pilot drill, countersink bur, core cutter bur and seating tool
Published
2020-07-07
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
EGGAttachment, Precision, All

Product Code Classifications

CodeDeviceSpecialtyClass
EGGAttachment, Precision, AllDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841549101830PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841549101830008415491018308415491018300841549101830

GMDN Terms

TermDefinition
Resilient dental precision attachmentA dental fixation device designed to give a tooth-borne/tissue-borne prosthesis sufficient mechanical play to withstand the variations in the seating of the prosthesis due to deformation of the underlying tissues, without placing excessive stress on the abutments.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
5082265660laura.greige@sterngold.com

Regulatory Flags

DUNS number
124763728
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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