FDA.report

Avalign

Primary DI
00190776075682
Brand
Avalign
Company
AVALIGN TECHNOLOGIES, INC.
Model
VM104-1917
Device description
French Pattern Osteotome,
Published
2021-11-03
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
false

Related Records

Contact Domains

Product Codes

CodeName
HWMOSTEOTOME

Product Code Classifications

CodeDeviceSpecialtyClass
HWMOsteotomeGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190776075682PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776075682001907760756821907760756820190776075682

GMDN Terms

TermDefinition
Dental osteotomeA hand-held, dental, surgical instrument used during dental osteotomy for shaping and condensing bone, typically when performing a dental implant surgical procedure. It is hand-held by the dentist who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The device will have a straight or bayonet-shaped handle leading to a round or concave tip at the distal end, which may be marked with graduations to indicate depth differences. It is used for ridge expanding, bone condensing and sinus floor elevation procedures. This device will be made of high-grade stainless steel. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(877)289-1096product.questions@avalign.com

Regulatory Flags

DUNS number
792528510
Device count
1
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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