FDA.reportPublic FDA data

BIOLIGHT

Primary DI
10667147100283
Brand
BIOLIGHT
Company
Synca Marketing Inc
Model
BDT13
Device description
BIOLIGHT DUAL REFILL #3
Published
2021-07-26
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELRPost, Root Canal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELRPost, Root CanalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10667147000286PrimaryGS10
10667147100283Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1066714700028610667147000286
1066714710028310667147100283

GMDN Terms#

Term, Definition table
TermDefinition
Root canal post, preformedA prefabricated endodontic rod designed for insertion into the root canal of a patient to support and retain a crown prosthesis. It is typically a solid, cylindrical, metal (e.g., stainless steel, gold alloy) piece with a proximal end appropriate to support the crown on top; it is, however, available in a variety of shapes, dimensions, and materials (e.g., ceramics, fibre-reinforced polymers). In addition, it is available in a variety of types (e.g., non-threaded, pre-threaded, or self-tapping; straight or tapered). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-667-9622XXX@X.XX

Regulatory Flags#

DUNS number
247111768
Device count
10
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00667147001552CadiV8CADI2021-07-15
10667147000095FIBER FORCEFF080022021-07-26
10667147000101FIBER FORCEFF080042021-07-26
10667147000118FIBER FORCEFF080112021-07-26
10667147000125FIBER FORCEFF080142021-07-26
10667147000187FAST SPLINT MATRIXFSM082021-07-26
10667147000194FAST SPLINT MATRIXFSM122021-07-26
10667147000200FAST SPLINT MATRIXFSM142021-07-26
10667147000224FAST SPLINT MATRIXFSM182021-07-26
10667147000255BIOLIGHTBDT052021-07-15
10667147000262BIOLIGHTBDT112021-07-26
10667147000279BIOLIGHTBDT122021-07-26
10667147000286BIOLIGHTBDT132021-07-26
10667147000347BIOLIGHTBST1002021-07-26
10667147000354BIOLIGHTBST1202021-07-26
10667147000361BIOLIGHTBST1352021-07-26
10667147000378BIOLIGHTBST1502021-07-26
10667147000460BIOLIGHT DRILL FREEBDF062023-02-13
10667147000477BIOLIGHT DRILL FREEBDF092023-02-13
10667147000484BIOLIGHT DRILL FREEBDF122023-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08059388441167Prosthetic Over Post # 0OVERFIBERS SRLELR2025-03-12
08059388441174Prosthetic Over Post # 1OVERFIBERS SRLELR2025-03-12
08059388441181Prosthetic Over Post # 2OVERFIBERS SRLELR2025-03-12
08059388441198Prosthetic Over Post # 3OVERFIBERS SRLELR2025-03-12
08059388441204Prosthetic Over Post # 4OVERFIBERS SRLELR2025-03-12
08059388441211Over Post+ # 0OVERFIBERS SRLELR2025-03-12
08059388441228Over Post+ # 1OVERFIBERS SRLELR2025-03-12
08059388441235Over Post+ # 2OVERFIBERS SRLELR2025-03-12
08059388441242Over Post+ # 3OVERFIBERS SRLELR2025-03-12
08059388441259Over Post+ # 4OVERFIBERS SRLELR2025-03-12
08059388441365Endodontic Over Post # 0OVERFIBERS SRLELR2025-03-12
08059388441372Endodontic Over Post # 1OVERFIBERS SRLELR2025-03-12
08059388441389Endodontic Over Post # 2OVERFIBERS SRLELR2025-03-12
08059388441396Endodontic Over Post # 3OVERFIBERS SRLELR2025-03-12
08059388441402Endodontic Over Post # 4OVERFIBERS SRLELR2025-03-12
08059388441518Duo Over Post # 1OVERFIBERS SRLELR2025-03-12
08059388441525Duo Over Post # 2OVERFIBERS SRLELR2025-03-12
08059388441556Polygon Over Post # 1OVERFIBERS SRLELR2025-03-12
08059388441563Polygon Over Post # 2OVERFIBERS SRLELR2025-03-12
08059388441570Polygon Over Post # 3OVERFIBERS SRLELR2025-03-12
08059388441617Hi-Rem Prosthetic Post # 0OVERFIBERS SRLELR2025-03-12
08059388441624Hi-Rem Prosthetic Post # 1OVERFIBERS SRLELR2025-03-12
08059388441631Hi-Rem Prosthetic Post # 2OVERFIBERS SRLELR2025-03-12
08059388441648Hi-Rem Prosthetic Post # 3OVERFIBERS SRLELR2025-03-12
08059388441655Hi-Rem+ # 0OVERFIBERS SRLELR2025-03-12
08059388441662Hi-Rem+ # 1OVERFIBERS SRLELR2025-03-12
08059388441679Hi-Rem+ # 2OVERFIBERS SRLELR2025-03-12
08059388441686Hi-Rem+ # 3OVERFIBERS SRLELR2025-03-12
08059388441778Hi-Rem Endodontic Post # 1OVERFIBERS SRLELR2025-03-12
08059388441785Hi-Rem Endodontic Post # 2OVERFIBERS SRLELR2025-03-12