FDA.report

IsoBlock

Primary DI
00883205018977
Brand
IsoBlock
Company
ULTRADENT PRODUCTS, INC.
Model
331
Catalog number
331
Device description
IsoBlock 10pk
Published
2017-09-20
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
EIGRETRACTOR, ALL TYPES

Product Code Classifications

CodeDeviceSpecialtyClass
EIGRetractor, All TypesDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00883205018977PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00883205018977008832050189778832050189770883205018977

GMDN Terms

TermDefinition
Dental occlusal splint, preformedA rigid or flexible prefabricated appliance that overlays the occlusal surfaces of the teeth. It is used to maintain the position of displaced or moveable teeth, to treat clenching and bruxism and their sequelae, and to provide temporary relief from muscle or temporo-mandibular joint (TMJ) pain (e.g., from TMJ dysfunction). It is typically made of standard, preformed materials or items for adaptation/direct insertion into the patient's mouth. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(801)572-4200customerservice@ultradent.com

Regulatory Flags

DUNS number
013369913
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
false

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