FDA.report

DURAGUARD

Primary DI
D746DGSC080X25R1
Brand
DURAGUARD
Company
RAINTREE ESSIX INC.
Model
DGSC080X25R
Catalog number
DGSC080X25R
Device description
DURAGUARD CLEAR .080 (2MM) ROUND 25PK.
Published
2016-09-24
Public version status
Update
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
MQCMouthguard, prescription

Product Code Classifications

CodeDeviceSpecialtyClass
MQCMouthguard, PrescriptionUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D746DGSC080X25R1PrimaryHIBCC0
D746DGSC080X25R0Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental implant template, radiographicA non-sterile device intended to be used by a dentist or a surgeon to radiographically determine the appropriate size of a dental implant to be inserted into the jawbone of a patient prior to dental surgery. It is typically made of a translucent plastic sheet marked with incremented graduations that correspond to the lengths of the implants available. The device is typically available in a set with graduated markings and an individual sheet is placed over the x-ray of the jawbone so that the final selection of implant size can be determined against the depth of bone shown by the x-ray. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)883-8733sales@essix.com

Regulatory Flags

DUNS number
801157132
Device count
25
DM exempt
true
Premarket exempt
false
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
true
Sterilization required before use
false

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D74627310991VISTADENT® OC27-310-9927-310-992016-09-24
D7462731099U1VISTADENT® OC27-310-99U27-310-99U2016-09-24
D7462731170L1VISTADENT® OC27-311-70L27-311-70L2016-09-24
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D746IEC0011ImprEssix®IEC001IEC0012016-09-24
D746IEC001201ImprEssix®IEC001-20IEC001-202016-09-24
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D746825301Thermoplier®82530825302016-09-24
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D746825601Thermoplier®82560825602016-09-24
D746825701Thermoplier®82570825702016-09-24
D746825901Thermoplier®82590825902016-09-24
D746826041Bonding Buttons82604826042016-09-24

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