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Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Physical Medicine Diagnostic Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
DZS
Capsule, Dental, Amalgam
1
Product Code
DYH
Adhesive, Bracket And Tooth Conditioner, Resin
2
Product Code
DZE
Implant, Endosseous, Root-Form
2
Product Code
EBC
Sealant, Pit And Fissure, And Conditioner
2
Product Code
EBD
Coating, Filling Material, Resin
2
Product Code
EBE
Coating, Denture Hydrophilic, Resin
2
Product Code
EBF
Material, Tooth Shade, Resin
2
Product Code
EBG
Crown And Bridge, Temporary, Resin
2
Product Code
EBH
Material, Impression Tray, Resin
1
Product Code
EBI
Resin, Denture, Relining, Repairing, Rebasing
2
Product Code
EBL
Pin, Retentive And Splinting, And Accessory Instruments
1
Product Code
EBO
Denture Repair Kit
2
Product Code
EBP
Reliner, Denture, Over The Counter
2
Product Code
EFD
Amalgamator, Dental, Ac-Powered
1
Product Code
EFT
Cleanser, Denture, Over The Counter
1
Product Code
EGG
Attachment, Precision, All
1
Product Code
EHE
Dispenser, Mercury And/Or Alloy
1
Product Code
EHO
Bar, Preformed
1
Product Code
EHP
Clasp, Preformed
1
Product Code
EHQ
Cusp, Preformed
1
Product Code
EHR
Pad, Denture, Over The Counter
2
Product Code
EHS
Cushion, Denture, Over The Counter
2
Product Code
EIT
Applicator, Rapid Wax, Dental
2
Product Code
EJH
Alloy, Metal, Base
2
Product Code
EJJ
Alloy, Amalgam
2
Product Code
EJK
Liner, Cavity, Calcium Hydroxide
2
Product Code
EJL
Bur, Dental
1
Product Code
EJP
Articulators
1
Product Code
EJS
Alloy, Other Noble Metal
2
Product Code
EJT
Alloy, Gold-Based Noble Metal
2
Product Code
EJW
Clasp, Wire
1
Product Code
EJX
Anchor, Preformed
1
Product Code
EKL
Point, Silver, Endodontic
1
Product Code
EKM
Gutta-Percha
1
Product Code
EKN
Point, Paper, Endodontic
1
Product Code
EKO
Denture Preformed (Partially Prefabricated Denture)
2
Product Code
ELE
Implant, Subperiosteal
2
Product Code
ELJ
Teeth, Artificial, Posterior With Metal Insert
1
Product Code
ELK
Teeth, Artificial, Backing And Facing
1
Product Code
ELL
Teeth, Porcelain
2
Product Code
ELM
Denture, Plastic, Teeth
2
Product Code
ELN
Teeth, Preformed Gold Denture
1
Product Code
ELO
Cusp, Gold And Stainless Steel
1
Product Code
ELR
Post, Root Canal
1
Product Code
ELS
Splint, Endodontic Stabilizing
2
Product Code
ELW
Material, Impression
2
Product Code
ELY
Mercury
2
Product Code
ELZ
Crown, Preformed
1
Product Code
EMA
Cement, Dental
2
Product Code
EMB
Zinc Oxide Eugenol
1
Product Code
JER
Cleaner, Denture, Mechanical
1
Product Code
KCR
Facebow
1
Product Code
KCS
Pantograph
1
Product Code
KIF
Resin, Root Canal Filling
2
Product Code
KLE
Agent, Tooth Bonding, Resin
2
Product Code
KOL
Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer
1
Product Code
KOM
Adhesive, Denture, Acacia And Karaya With Sodium Borate
1
Product Code
KON
Adhesive, Denture, Polyacrylamide Polymer (Modified Cationic)
3
Product Code
KOO
Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt
1
Product Code
KOP
Adhesive, Denture, Karaya
1
Product Code
KOQ
Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&)
1
Product Code
KOR
Adhesive, Denture, Karaya With Sodium Borate
3
Product Code
KOS
Adhesive, Denture, Carboxymethylcellulose Sodium And Cationic Polyacrylamide Polymer
3
Product Code
KOT
Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium
1
Product Code
KXR
Applicator, Resin
1
Product Code
KXW
Adhesive, Denture, Carboxymethylcellulose Sodium (49%) And Ethylene-Oxide Homopolymer
1
Product Code
KXX
Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer
1
Product Code
KXY
Polyvinyl Methylether Maleic Anhydride &/Or Acid Copolymer & Carboxymethylce
3
Product Code
KZN
Scanner, Color
2
Product Code
KZO
Ink, Arch Tracing
1
Product Code
KZP
Solution, Cement Dissolving
2
Product Code
LBH
Varnish, Cavity
2
Product Code
LPK
Bone Grafting Material, For Dental Bone Repair
2
Product Code
LYC
Bone Grafting Material, Synthetic
2
Product Code
K
21
3260
CMFlexTM
2
Cleared 510(K)
K
20
2675
InRoad® Dental Synthetic Bone Graft
2
Cleared 510(K)
K
20
1546
OsOpia Synthetic Bone Void Filler
2
Cleared 510(K)
K
20
1051
Straumann BoneCeramic
2
Cleared 510(K)
K
19
2597
Cytrans Granules
2
Cleared 510(K)
K
15
3676
OSTEON III
2
Cleared 510(K)
K
15
3230
ShefaBone SCPC Resorbable Bone Graft
2
Cleared 510(K)
K
14
0374
MASTERGRAFT PUTTY
2
Cleared 510(K)
K
12
1177
BOND APATITE
2
Cleared 510(K)
K
13
1385
EASY-GRAFT
2
Cleared 510(K)
K
11
1105
CURASAN OSSEOLIVE DENTAL
2
Cleared 510(K)
K
11
3282
CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO
2
Cleared 510(K)
K
12
2240
BONE PLUS BCP EAGLE EYE
2
Cleared 510(K)
K
11
3049
SOCKET GRAFT
2
Cleared 510(K)
K
11
2716
OSTEON II
2
Cleared 510(K)
K
11
0198
BLUE SKY BIO TCP
2
Cleared 510(K)
K
11
2428
NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFT
2
Cleared 510(K)
K
11
1087
FOUNDATION
2
Cleared 510(K)
K
10
3820
REPROBONE DENTAL GRAFTING MATERIAL
2
Cleared 510(K)
K
11
0449
ENDOBON XENOGRAFT GRANULES
2
Cleared 510(K)
K
10
2208
NANOGEN
2
Cleared 510(K)
K
10
1827
OSTEOSCAF
2
Cleared 510(K)
K
10
3709
CERACELL DENTAL
2
Cleared 510(K)
K
10
2872
OSBONE DENTAL
2
Cleared 510(K)
K
10
0883
CARRIGEN
2
Cleared 510(K)
K
10
2812
GAMMA-BSM; BETA-BSM; EQUIVABONE
2
Cleared 510(K)
K
10
2015
OSTEON, OSTEON SINUS, OSTEON LIFTING
2
Cleared 510(K)
K
10
1718
OSSEOCONDUCT
2
Cleared 510(K)
K
10
1014
BOND BONE
2
Cleared 510(K)
K
09
1618
VITOMATRIX
2
Cleared 510(K)
K
10
1426
CEROS TCP GRANULES
2
Cleared 510(K)
K
09
0950
BONE PLUS BCP
2
Cleared 510(K)
K
09
2194
POLYBONE DENTAL
2
Cleared 510(K)
K
09
3390
HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025
2
Cleared 510(K)
K
09
3871
PERIOPHIL B-TCP
2
Cleared 510(K)
K
10
0671
NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT
2
Cleared 510(K)
K
09
3122
MBCP+
2
Cleared 510(K)
K
09
2087
MEDTRONIC DENTAL TCP
2
Cleared 510(K)
K
09
1729
ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE
2
Cleared 510(K)
K
09
2788
PERIOPHIL BIPHASIC
2
Cleared 510(K)
K
08
3372
ARROWBONE-A, ARROWBONE-B
2
Cleared 510(K)
K
09
2567
MODIFICATION TO UNIGRAFT
2
Cleared 510(K)
K
09
0850
ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE
2
Cleared 510(K)
K
09
1484
NOVABONE DENTAL PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT
2
Cleared 510(K)
K
09
0793
BONGROS HA
2
Cleared 510(K)
K
09
0083
CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090
2
Cleared 510(K)
K
08
3858
BOND BONE
2
Cleared 510(K)
K
08
3005
NANGEL
2
Cleared 510(K)
K
08
2286
BIOACTYS
2
Cleared 510(K)
K
08
3742
SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX
2
Cleared 510(K)
K
08
2917
MASTERGRAFT RESORBABLE CERAMIC GRANULES
2
Cleared 510(K)
K
08
1784
MASTERGRAFT PUTTY
2
Cleared 510(K)
K
08
2383
FORTOSS VITAL
2
Cleared 510(K)
K
08
1432
HEALOS II BONE GRAFT SUBSTITUTE
2
Cleared 510(K)
K
08
1721
TRICOS A RESORBABLE SUBSTITUTE
2
Cleared 510(K)
K
08
1561
OSFERION D
2
Cleared 510(K)
K
08
0772
BONEMEDIK-DM
2
Cleared 510(K)
K
08
0308
BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLD
2
Cleared 510(K)
K
07
3571
TRICOS T RESORBABLE BONE SUBSTITUTE
2
Cleared 510(K)
K
07
2397
SYNOSS SYNTHETIC BONE GRAFT MATERIAL
2
Cleared 510(K)
K
07
1817
OSTEOGRAF/N-300
2
Cleared 510(K)
K
07
2052
OSTEOGRAF/D-300
2
Cleared 510(K)
K
07
2056
OSTEOGRAF/D-700
2
Cleared 510(K)
K
07
2057
OSTEOGRAF/LD-300
2
Cleared 510(K)
K
07
2058
MODIFICATION TO: OSTEOGRAF/N-700
2
Cleared 510(K)
K
07
0784
INION BIORESTORE
2
Cleared 510(K)
K
07
0055
BONALIVE GRANULES AND BONALIVE PLATES
2
Cleared 510(K)
K
06
3634
RTR SYRINGE
2
Cleared 510(K)
K
06
2834
OSTEON, MODELS GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050
2
Cleared 510(K)
K
06
2102
ODONCER
2
Cleared 510(K)
K
06
3596
PERIOGLAS PUTTY-BIOACTIVE BONE GRAFT GEL
2
Cleared 510(K)
K
06
3549
NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT
2
Cleared 510(K)
K
06
3010
REGEN BIOCEMENT
2
Cleared 510(K)
K
05
2493
SOCKET GRAFT
2
Cleared 510(K)
K
06
0732
MBCP GEL
2
Cleared 510(K)
K
06
0285
BONEGEN - TR
2
Cleared 510(K)
K
05
3374
OSSAPLAST DENTAL (PARTICLE SIZE OF 500 TO 1000 UM TO 2000 UM)
2
Cleared 510(K)
K
05
3387
PERIOGLAS BONE GRAFT PARTICULATE
2
Cleared 510(K)
K
05
3022
SYNTHES (USA) CHRONOS-BETA-TCP
2
Cleared 510(K)
K
05
1885
MBCP
2
Cleared 510(K)
K
05
1091
SYNTHOGRAFT
2
Cleared 510(K)
K
05
0170
FORTOSS VITAL BONE GRAFT SUBSTITUTE
2
Cleared 510(K)
K
05
0984
BIOPLANT
2
Cleared 510(K)
K
05
1443
CERASORB DENTAL, CERASORB M DENTAL AND CERASORB PERIO
2
Cleared 510(K)
K
04
2583
CALC-I-OSS
2
Cleared 510(K)
K
05
1381
ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE
2
Cleared 510(K)
K
05
0260
BIORESORB MACRO PORE
2
Cleared 510(K)
K
04
2730
CALFORMA CALCIUM SULFATE BONE GRAFT BARRIER, MODEL 0.5G/1.0G
2
Cleared 510(K)
K
03
0052
OSTIM
2
Cleared 510(K)
K
04
2706
OSSATURA DENTAL
2
Cleared 510(K)
K
04
0783
FOUNDATION
2
Cleared 510(K)
K
03
1813
OSSATURA DENTAL
2
Cleared 510(K)
K
04
1324
CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER
2
Cleared 510(K)
K
03
0195
BBP BONE SUBSTITUTES
2
Cleared 510(K)
K
04
0646
STRAUMANN GRANULES
2
Cleared 510(K)
K
03
3098
OSTEOGEN SBRG
2
Cleared 510(K)
K
03
3994
NOVABONE-BBG-RESORBABLE BONE GRAFT SUBSTITUTE
2
Cleared 510(K)
K
03
3729
COLLAGEN DENTAL WOUND DRESSINGS
2
Cleared 510(K)
K
04
0278
PERIOGLAS-BIOGLASS BONE GRAFT SUBSTITUTE
2
Cleared 510(K)
K
03
3110
C-GRAFT
2
Cleared 510(K)
K
03
1073
PERIOGLAS PLUS - SETTABLE BONE GRAFT SUBSTITUTE
2
Cleared 510(K)
K
03
0682
CALCIUM HYDROXYLAPATITE IMPLANT, ICC AND 0.5CC, MODELS 8038-3, 8037-3
2
Cleared 510(K)
K
02
3998
THERIRIDGE BLOCK, BONE GRAFT SUBSTITUTE
2
Cleared 510(K)
K
02
3799
FRIOS ALGIPORE
2
Cleared 510(K)
K
02
0720
OSSIFORM
2
Cleared 510(K)
K
02
0396
BIOCELLECT -PERIO
2
Cleared 510(K)
K
01
4289
ORTHOSS RESORBABLE BONE VOID FILLER
2
Cleared 510(K)
K
01
3346
GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE
2
Cleared 510(K)
K
01
2144
CYTOFLEX
2
Cleared 510(K)
K
01
2047
3I CALCIUM SULFATE BONE CEMENT
2
Cleared 510(K)
K
01
1403
SURGIPLASTER CALCIUM SULFATE HEMIHYDRATE
2
Cleared 510(K)
K
01
1032
SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE GRAFT LIQUID APPLICATOR (DUAL LUMEN CANNULA
2
Cleared 510(K)
K
01
0775
BIOCELLECT
2
Cleared 510(K)
K
01
0701
MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VOID FILLER
2
Cleared 510(K)
K
00
3494
MIMIX BONE REPLACEMENT SYSTEM
2
Cleared 510(K)
K
01
0320
MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM
2
Cleared 510(K)
K
00
3493
3I CALCIUM SODIUM PHOSPHATE BONE CEMENT
2
Cleared 510(K)
K
00
3286
SYMPHONY GRAFT DELIVERY SYSTEM
2
Cleared 510(K)
K
00
3457
UNIGRAFT
2
Cleared 510(K)
K
99
4137
ATRISORB-D FREEFLOW BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER WITH 4% DOXYCYCLINE
2
Cleared 510(K)
K
00
1598
BIOBAR, IMPLANTABLE BIODEGRADABLE COLLAGEN MEMBRANE FOR GUIDED BONE REGENERATION
2
Cleared 510(K)
K
97
0569
BIO-BLOCKS
2
Cleared 510(K)
K
00
0633
SYNTHETIC GLASS BONE GRAFT MATERIAL
2
Cleared 510(K)
K
99
3610
CYTOPLAST RESORB, MODELS R-250, RP-250, RU-250, RPS-250, RPL-250
2
Cleared 510(K)
K
00
0149
NOVABONE-BIOGLASS BONE GRAFT PARTICULATE
2
Cleared 510(K)
K
99
3784
UNIGRAFT
2
Cleared 510(K)
K
99
3238
FORTOSS-CEMA
2
Cleared 510(K)
K
99
0537
OSTEO-PIN MEMBRANE FIXATION PIN
2
Cleared 510(K)
K
99
2416
PERIOGLAS- BIOGLASS BONE GRAFT PARTICULATE
2
Cleared 510(K)
K
99
2216
BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANE
2
Cleared 510(K)
K
98
3104
NORIAN PERIODONTAL/DENTAL CEMENT (PDC)
2
Cleared 510(K)
K
98
2699
UNIGRAFE
2
Cleared 510(K)
K
97
4399
BIO-OSS COLLAGEN
2
Cleared 510(K)
K
97
0321
BIO-OSS ANORGANIC BOVINE BONE
2
Cleared 510(K)
K
97
2817
RESOR-PIN RESORBABLE MEMBRANE PIN
2
Cleared 510(K)
K
98
1182
OSTEOGRAF/N-300
2
Cleared 510(K)
K
98
1214
OSTEOGRAF/N-700
2
Cleared 510(K)
K
98
0679
ENDOBON
2
Cleared 510(K)
K
97
3594
GORE RESOLUT XT REGENERATIVE MATERIAL
2
Cleared 510(K)
K
97
2842
INTERPORE INDUCER BONE GRAFT DELIVERY SYRINGE
2
Cleared 510(K)
K
97
2278
CYTOPLAST REGENTEX TITANIUM 250
2
Cleared 510(K)
K
96
2548
BSM BONE SUBSTITUTE MATERIAL KIT
2
Cleared 510(K)
K
97
0884
RESOLUT REGENERATIVE MATERIAL
2
Cleared 510(K)
K
96
4342
CYTOPLAST GBR
2
Cleared 510(K)
K
96
0267
TBM SPONGE
2
Cleared 510(K)
K
94
0643
OSMED EPI-GUIDE
2
Cleared 510(K)
K
96
2624
RESOLUT REGENERATIVE MATERIAL
2
Cleared 510(K)
K
96
2494
PERIOGLAS - BIOGLASS BONE GRAFT PARTICULATE
2
Cleared 510(K)
K
96
2838
PERMARIDGE SYRINGE
2
Cleared 510(K)
K
96
2786
OSTEOGRAF STAINLESS STEEL SYRING
2
Cleared 510(K)
K
96
0348
OSTEOGRAF/N-300 HYDROXYLAPATITE
2
Cleared 510(K)
K
96
0368
OSTEOGRAFT/N-700 HYDROXYLAPTITE
2
Cleared 510(K)
K
96
0353
OSTEOGRAF/LD-300 HYDROXYLAPATITE
2
Cleared 510(K)
K
96
0361
PERMAMESH-D HYDROXYLAPATITE MATRIX
2
Cleared 510(K)
K
96
0164
BIO-INTERFACES, INC., BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BII-GRAFT 6140
2
Cleared 510(K)
K
95
0306
IMTEC BIOBARRIER
2
Cleared 510(K)
K
95
5096
CAPSET CALCIUM SULFATE BONE GRAFT PLASTER
2
Cleared 510(K)
K
95
4763
BIO-INTERFACES, INC,. BII-PLAST
2
Cleared 510(K)
K
95
4631
OSTEOGRAF/N-BLOCCK HYDROXYLAPATITE
2
Cleared 510(K)
K
95
2922
BIOGRAN BIOACTIVE GLASS SYNTHETIC BONE GRAFT MATERIAL
2
Cleared 510(K)
K
95
2619
BIO-OSS CERAMIC
2
Cleared 510(K)
K
95
2618
BIO-OSS
2
Cleared 510(K)
K
95
0598
BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BLL-GRAFT
2
Cleared 510(K)
K
92
4408
COLLA-TEC ABSORBABLE COLLAGEN MEMBRANE
2
Cleared 510(K)
K
95
2617
BIO-OSS
2
Cleared 510(K)
K
92
3310
OSTEOGEN (HA RESORB)
2
Cleared 510(K)
K
95
0567
BIO-APATITE 6140 HA PARTICLES
2
Cleared 510(K)
K
95
0511
BLL-FIL 6140 PARTICLES
2
Cleared 510(K)
K
94
3186
CAPSET CALCIUM SULFATE BONE GRAFT PLASTER
2
Cleared 510(K)
K
95
0165
INTERPORE IP 200 GRANULAR CORALLINE HYDROXYAPATITE BONE VOID FILLERS, 425 TO 1000 MICRONS AND 425 TO 600 MICRONS
2
Cleared 510(K)
K
93
2866
RESOLUT REGENERATIVE MATERIAL
2
Cleared 510(K)
K
94
1780
ORTHOVITA BIOGRAN
2
Cleared 510(K)
K
94
2946
OSTEOGRAF/D-100 HYDROXYLAPATITE
2
Cleared 510(K)
K
94
2212
OSTEOGRAF/LD-300 HYDROXYLAPATITE
2
Cleared 510(K)
K
93
4049
BII-PORE(TM) CANAL WALL PROSTHESIS
2
Cleared 510(K)
K
93
3688
BII-PORE
2
Cleared 510(K)
K
93
4430
BON APATITE HA PARTICLES
2
Cleared 510(K)
K
93
4947
BII-PLAST
2
Cleared 510(K)
K
93
0115
PERIOGLASS
2
Cleared 510(K)
K
92
4287
710 POROUS HA PARTICLES-BII-PORE
2
Cleared 510(K)
K
92
4288
B1018 POROUS HA BII-PORE
2
Cleared 510(K)
K
92
4286
4060 POROUS HA PARTICULES BII PORE
2
Cleared 510(K)
K
92
2487
BIO-INTERFACES 1840 POROUS HA PARTICLES-BII-PORE
2
Cleared 510(K)
K
92
1776
1840 HA PARTICLES
2
Cleared 510(K)
K
92
0508
BIO-OSS BLOCKS
2
Cleared 510(K)
K
92
1468
PERMAMESH HYDROXYLAPATITE MATRIX
2
Cleared 510(K)
K
92
1469
OSTEOGRAF/N-700 NATURAL HYDROXYLAPATITE 18-40 MESH
2
Cleared 510(K)
K
91
0432
HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER
2
Cleared 510(K)
K
90
0136
CEROS 80 (HA)
2
Cleared 510(K)
K
90
2295
OSTEOGRAF/N NATURAL HYDROXYLAPATITE, 40-60 MESH
2
Cleared 510(K)
K
89
1173
OSTEOGRAF/P PERIODONTAL HYDROXYLAPATITE, 40-60
2
Cleared 510(K)
K
88
5067
4060 HA PARTICLES
2
Cleared 510(K)
K
88
0371
BIOGLASS DENTAL ENDOSSEOUS RIDGE MAINTAINER
2
Cleared 510(K)
K
88
2098
DENTORIDGE(TM) HYDROXYYLAPATITE
2
Cleared 510(K)
K
87
3763
BIO-OSS - CERAMIC PURE NATURAL HYDROXYAPATITE
2
Cleared 510(K)
K
87
1773
BIO-OSS PURE NAT HYDROXYAPATITE ENDOSS IMPLANT
2
Cleared 510(K)
K
86
3237
HYDROXYLAPATITE BONE GRAFT MATERIAL
2
Cleared 510(K)
K
86
3176
ADDITIONAL CLINICAL USAGES FOR OSTEOGRAF/AR & AR+
2
Cleared 510(K)
K
86
2324
OSTEOGRAF/AR AND OSTEOGRAF/AR+
2
Cleared 510(K)
K
86
2061
OSTEOGRAF/AR+ PERMARIDGE HYDROXYLAPATITE, 18-40
2
Cleared 510(K)
K
86
1041
ENHANCE
2
Cleared 510(K)
K
86
0983
INTERPORE 200 POROUS HYDROXYAPATITE
2
Cleared 510(K)
K
86
1084
OSTEOGRAF/AR ALVEOLAR RID HYDROX, 18-40 MESH
2
Cleared 510(K)
K
86
1083
OSTEOGRAF/AR+(PLUS) ALVEOLAR RID HYDROX 18-40 MESH
2
Cleared 510(K)
K
85
2766
HA-1000 & HA-500 HYDROXYLAPATITE TOOTH ROOT SUBSTI
2
Cleared 510(K)
K
85
2199
OSTEOGRAF 2040 OSTEOGRAF 4060
2
Cleared 510(K)
K
85
2742
OSTEOGRAF AR ALVEOLAR RIDGE HYDROXYLAPATITE 18-40
2
Cleared 510(K)
K
85
2765
HA-2000 HYDROXYLAPATITE
2
Cleared 510(K)
K
85
2682
CALCITITE BONE GRAFT MAT/ORAL & MAXILLOFACIAL SURG
2
Cleared 510(K)
K
85
0012
ALLOTROPAT/HEYLTEX CORP. BONE GRAFTING DENSE HYDRO
2
Cleared 510(K)
K
84
3398
OSTEOGEN
2
Cleared 510(K)
K
84
2718
HYDROXYAPATITE
2
Cleared 510(K)
K
84
3154
TOOTH ROOT SOCKET GAUGE
2
Cleared 510(K)
K
84
3153
ANTERIOR ALVEOLAR RIDGE SIZER
2
Cleared 510(K)
K
84
2163
RIDGEMATRIX 20/40 MESH, PERIOMATRIX
2
Cleared 510(K)
K
84
1201
POROUS HYDROXYAPATITE BG200
2
Cleared 510(K)
K
84
0260
PERIOGRAF DURAPATITE 40-60 MESH
2
Cleared 510(K)
K
83
2509
MBS HARD TISSUE REPLACEMENT SYSTEM
2
Cleared 510(K)
K
83
0304
REPLAM HYDROXYAPATITE
2
Cleared 510(K)
K
82
1752
SYNTHOGRAFT LG-AUGMENTATION & BONE FILL
2
Cleared 510(K)
K
82
0023
CONAGRAF TM DURAPATITE CONES
2
Cleared 510(K)
K
81
3070
PERIOGRAF
2
Cleared 510(K)
K
81
1101
HYDROXYLAPATITE
2
Cleared 510(K)
K
81
0382
HYDROXYLAPATITE ALVEOLAR RIDGE MAIN
2
Cleared 510(K)
K
79
1416
PYROLITE CARBON ALVEOLAR MAINTEN IMPLANT
2
Cleared 510(K)
LZD
Joint, Temporomandibular, Implant
3
Product Code
MMT
Resin, Root Canal Filling Containing Chloroform
3
Product Code
MMU
Adhesive, Denture, Acacia And Karaya With Sodium Borate > 12% By Weight
3
Product Code
MPI
Glenoid Fossa Prosthesis
3
Product Code
MPJ
Interarticular Disc Prosthesis (Interpositional Implant)
3
Product Code
MPL
Mandibular Condyle Prosthesis
3
Product Code
MZW
Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief
2
Product Code
NDP
Accessories, Implant, Dental, Endosseous
1
Product Code
NFE
Materials, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Alveolar Ridge Augmentation
2
Product Code
NHA
Abutment, Implant, Dental, Endosseous
2
Product Code
NKJ
Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter
1
Product Code
NME
Bur, Diamond Coated, Reprocessed
1
Product Code
NOF
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
2
Product Code
NPK
Barrier, Synthetic, Intraoral
2
Product Code
NPL
Barrier, Animal Source, Intraoral
2
Product Code
NPM
Bone Grafting Material, Animal Source
2
Product Code
NPZ
Bone Grafting Material, Dental, With Biologic Component
3
Product Code
NQA
Biologic Material, Dental
3
Product Code
NRQ
Blade-Form Endosseous Dental Implant
2
Product Code
NUN
Bone Grafting Material, Human Source
2
Product Code
NUX
Cleanser, Denture, Prescription
1
Product Code
NYD
Endodontic Kit
2
Product Code
OAT
Implant, Endosseous, Orthodontic
2
Product Code
NYE
Fixture Mount Kit
1
Product Code
OFW
Restorative Instrument And Component Tray
2
Product Code
OFY
Dental Implant Surgical Tray
1
Product Code
OIV
Dental Amalgam
2
Product Code
PHR
Diammine Silver Fluoride Dental Hypersensitivity Varnish
2
Product Code
PME
External Cleaning Solution
2
Product Code
PNP
Dental Abutment Design Software For Dental Laboratory
2
Product Code
POW
Crown And Bridge, Long-Term Temporary, Resin
2
Product Code
PZY
Additively Manufactured, Preformed, Resin Denture Tooth
2
Product Code
QJK
Intraoral Camera
2
Product Code
QRQ
Non-Irrigation Endosseous Dental Implant Drill Bits
1
Product Code
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
Subpart G—Miscellaneous Devices
CFR Sub-Part
Ear, Nose, Throat
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Last synced on 16 August 2024 at 11:05 pm
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subpart-d—prosthetic-devices
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K103820
View Source
REPROBONE DENTAL GRAFTING MATERIAL
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K103820
510(k) Type
Traditional
Applicant
CERAMISYS LTD
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/3/2011
Days to Decision
308 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Miscellaneous
Subpart B—Diagnostic Devices
Subpart B—Physical Medicine Diagnostic Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart D—Prosthetic Devices
DZS
Capsule, Dental, Amalgam
DYH
Adhesive, Bracket And Tooth Conditioner, Resin
DZE
Implant, Endosseous, Root-Form
EBC
Sealant, Pit And Fissure, And Conditioner
EBD
Coating, Filling Material, Resin
EBE
Coating, Denture Hydrophilic, Resin
EBF
Material, Tooth Shade, Resin
EBG
Crown And Bridge, Temporary, Resin
EBH
Material, Impression Tray, Resin
EBI
Resin, Denture, Relining, Repairing, Rebasing
EBL
Pin, Retentive And Splinting, And Accessory Instruments
EBO
Denture Repair Kit
EBP
Reliner, Denture, Over The Counter
EFD
Amalgamator, Dental, Ac-Powered
EFT
Cleanser, Denture, Over The Counter
EGG
Attachment, Precision, All
EHE
Dispenser, Mercury And/Or Alloy
EHO
Bar, Preformed
EHP
Clasp, Preformed
EHQ
Cusp, Preformed
EHR
Pad, Denture, Over The Counter
EHS
Cushion, Denture, Over The Counter
EIT
Applicator, Rapid Wax, Dental
EJH
Alloy, Metal, Base
EJJ
Alloy, Amalgam
EJK
Liner, Cavity, Calcium Hydroxide
EJL
Bur, Dental
EJP
Articulators
EJS
Alloy, Other Noble Metal
EJT
Alloy, Gold-Based Noble Metal
EJW
Clasp, Wire
EJX
Anchor, Preformed
EKL
Point, Silver, Endodontic
EKM
Gutta-Percha
EKN
Point, Paper, Endodontic
EKO
Denture Preformed (Partially Prefabricated Denture)
ELE
Implant, Subperiosteal
ELJ
Teeth, Artificial, Posterior With Metal Insert
ELK
Teeth, Artificial, Backing And Facing
ELL
Teeth, Porcelain
ELM
Denture, Plastic, Teeth
ELN
Teeth, Preformed Gold Denture
ELO
Cusp, Gold And Stainless Steel
ELR
Post, Root Canal
ELS
Splint, Endodontic Stabilizing
ELW
Material, Impression
ELY
Mercury
ELZ
Crown, Preformed
EMA
Cement, Dental
EMB
Zinc Oxide Eugenol
JER
Cleaner, Denture, Mechanical
KCR
Facebow
KCS
Pantograph
KIF
Resin, Root Canal Filling
KLE
Agent, Tooth Bonding, Resin
KOL
Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer
KOM
Adhesive, Denture, Acacia And Karaya With Sodium Borate
KON
Adhesive, Denture, Polyacrylamide Polymer (Modified Cationic)
KOO
Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt
KOP
Adhesive, Denture, Karaya
KOQ
Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&)
KOR
Adhesive, Denture, Karaya With Sodium Borate
KOS
Adhesive, Denture, Carboxymethylcellulose Sodium And Cationic Polyacrylamide Polymer
KOT
Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium
KXR
Applicator, Resin
KXW
Adhesive, Denture, Carboxymethylcellulose Sodium (49%) And Ethylene-Oxide Homopolymer
KXX
Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer
KXY
Polyvinyl Methylether Maleic Anhydride &/Or Acid Copolymer & Carboxymethylce
KZN
Scanner, Color
KZO
Ink, Arch Tracing
KZP
Solution, Cement Dissolving
LBH
Varnish, Cavity
LPK
Bone Grafting Material, For Dental Bone Repair
LYC
Bone Grafting Material, Synthetic
K
21
3260
CMFlexTM
K
20
2675
InRoad® Dental Synthetic Bone Graft
K
20
1546
OsOpia Synthetic Bone Void Filler
K
20
1051
Straumann BoneCeramic
K
19
2597
Cytrans Granules
K
15
3676
OSTEON III
K
15
3230
ShefaBone SCPC Resorbable Bone Graft
K
14
0374
MASTERGRAFT PUTTY
K
12
1177
BOND APATITE
K
13
1385
EASY-GRAFT
K
11
1105
CURASAN OSSEOLIVE DENTAL
K
11
3282
CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO
K
12
2240
BONE PLUS BCP EAGLE EYE
K
11
3049
SOCKET GRAFT
K
11
2716
OSTEON II
K
11
0198
BLUE SKY BIO TCP
K
11
2428
NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFT
K
11
1087
FOUNDATION
K
10
3820
REPROBONE DENTAL GRAFTING MATERIAL
K
11
0449
ENDOBON XENOGRAFT GRANULES
K
10
2208
NANOGEN
K
10
1827
OSTEOSCAF
K
10
3709
CERACELL DENTAL
K
10
2872
OSBONE DENTAL
K
10
0883
CARRIGEN
K
10
2812
GAMMA-BSM; BETA-BSM; EQUIVABONE
K
10
2015
OSTEON, OSTEON SINUS, OSTEON LIFTING
K
10
1718
OSSEOCONDUCT
K
10
1014
BOND BONE
K
09
1618
VITOMATRIX
K
10
1426
CEROS TCP GRANULES
K
09
0950
BONE PLUS BCP
K
09
2194
POLYBONE DENTAL
K
09
3390
HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025
K
09
3871
PERIOPHIL B-TCP
K
10
0671
NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT
K
09
3122
MBCP+
K
09
2087
MEDTRONIC DENTAL TCP
K
09
1729
ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE
K
09
2788
PERIOPHIL BIPHASIC
K
08
3372
ARROWBONE-A, ARROWBONE-B
K
09
2567
MODIFICATION TO UNIGRAFT
K
09
0850
ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE
K
09
1484
NOVABONE DENTAL PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT
K
09
0793
BONGROS HA
K
09
0083
CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090
K
08
3858
BOND BONE
K
08
3005
NANGEL
K
08
2286
BIOACTYS
K
08
3742
SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX
K
08
2917
MASTERGRAFT RESORBABLE CERAMIC GRANULES
K
08
1784
MASTERGRAFT PUTTY
K
08
2383
FORTOSS VITAL
K
08
1432
HEALOS II BONE GRAFT SUBSTITUTE
K
08
1721
TRICOS A RESORBABLE SUBSTITUTE
K
08
1561
OSFERION D
K
08
0772
BONEMEDIK-DM
K
08
0308
BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLD
K
07
3571
TRICOS T RESORBABLE BONE SUBSTITUTE
K
07
2397
SYNOSS SYNTHETIC BONE GRAFT MATERIAL
K
07
1817
OSTEOGRAF/N-300
K
07
2052
OSTEOGRAF/D-300
K
07
2056
OSTEOGRAF/D-700
K
07
2057
OSTEOGRAF/LD-300
K
07
2058
MODIFICATION TO: OSTEOGRAF/N-700
K
07
0784
INION BIORESTORE
K
07
0055
BONALIVE GRANULES AND BONALIVE PLATES
K
06
3634
RTR SYRINGE
K
06
2834
OSTEON, MODELS GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050
K
06
2102
ODONCER
K
06
3596
PERIOGLAS PUTTY-BIOACTIVE BONE GRAFT GEL
K
06
3549
NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT
K
06
3010
REGEN BIOCEMENT
K
05
2493
SOCKET GRAFT
K
06
0732
MBCP GEL
K
06
0285
BONEGEN - TR
K
05
3374
OSSAPLAST DENTAL (PARTICLE SIZE OF 500 TO 1000 UM TO 2000 UM)
K
05
3387
PERIOGLAS BONE GRAFT PARTICULATE
K
05
3022
SYNTHES (USA) CHRONOS-BETA-TCP
K
05
1885
MBCP
K
05
1091
SYNTHOGRAFT
K
05
0170
FORTOSS VITAL BONE GRAFT SUBSTITUTE
K
05
0984
BIOPLANT
K
05
1443
CERASORB DENTAL, CERASORB M DENTAL AND CERASORB PERIO
K
04
2583
CALC-I-OSS
K
05
1381
ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE
K
05
0260
BIORESORB MACRO PORE
K
04
2730
CALFORMA CALCIUM SULFATE BONE GRAFT BARRIER, MODEL 0.5G/1.0G
K
03
0052
OSTIM
K
04
2706
OSSATURA DENTAL
K
04
0783
FOUNDATION
K
03
1813
OSSATURA DENTAL
K
04
1324
CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER
K
03
0195
BBP BONE SUBSTITUTES
K
04
0646
STRAUMANN GRANULES
K
03
3098
OSTEOGEN SBRG
K
03
3994
NOVABONE-BBG-RESORBABLE BONE GRAFT SUBSTITUTE
K
03
3729
COLLAGEN DENTAL WOUND DRESSINGS
K
04
0278
PERIOGLAS-BIOGLASS BONE GRAFT SUBSTITUTE
K
03
3110
C-GRAFT
K
03
1073
PERIOGLAS PLUS - SETTABLE BONE GRAFT SUBSTITUTE
K
03
0682
CALCIUM HYDROXYLAPATITE IMPLANT, ICC AND 0.5CC, MODELS 8038-3, 8037-3
K
02
3998
THERIRIDGE BLOCK, BONE GRAFT SUBSTITUTE
K
02
3799
FRIOS ALGIPORE
K
02
0720
OSSIFORM
K
02
0396
BIOCELLECT -PERIO
K
01
4289
ORTHOSS RESORBABLE BONE VOID FILLER
K
01
3346
GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE
K
01
2144
CYTOFLEX
K
01
2047
3I CALCIUM SULFATE BONE CEMENT
K
01
1403
SURGIPLASTER CALCIUM SULFATE HEMIHYDRATE
K
01
1032
SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE GRAFT LIQUID APPLICATOR (DUAL LUMEN CANNULA
K
01
0775
BIOCELLECT
K
01
0701
MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VOID FILLER
K
00
3494
MIMIX BONE REPLACEMENT SYSTEM
K
01
0320
MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM
K
00
3493
3I CALCIUM SODIUM PHOSPHATE BONE CEMENT
K
00
3286
SYMPHONY GRAFT DELIVERY SYSTEM
K
00
3457
UNIGRAFT
K
99
4137
ATRISORB-D FREEFLOW BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER WITH 4% DOXYCYCLINE
K
00
1598
BIOBAR, IMPLANTABLE BIODEGRADABLE COLLAGEN MEMBRANE FOR GUIDED BONE REGENERATION
K
97
0569
BIO-BLOCKS
K
00
0633
SYNTHETIC GLASS BONE GRAFT MATERIAL
K
99
3610
CYTOPLAST RESORB, MODELS R-250, RP-250, RU-250, RPS-250, RPL-250
K
00
0149
NOVABONE-BIOGLASS BONE GRAFT PARTICULATE
K
99
3784
UNIGRAFT
K
99
3238
FORTOSS-CEMA
K
99
0537
OSTEO-PIN MEMBRANE FIXATION PIN
K
99
2416
PERIOGLAS- BIOGLASS BONE GRAFT PARTICULATE
K
99
2216
BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANE
K
98
3104
NORIAN PERIODONTAL/DENTAL CEMENT (PDC)
K
98
2699
UNIGRAFE
K
97
4399
BIO-OSS COLLAGEN
K
97
0321
BIO-OSS ANORGANIC BOVINE BONE
K
97
2817
RESOR-PIN RESORBABLE MEMBRANE PIN
K
98
1182
OSTEOGRAF/N-300
K
98
1214
OSTEOGRAF/N-700
K
98
0679
ENDOBON
K
97
3594
GORE RESOLUT XT REGENERATIVE MATERIAL
K
97
2842
INTERPORE INDUCER BONE GRAFT DELIVERY SYRINGE
K
97
2278
CYTOPLAST REGENTEX TITANIUM 250
K
96
2548
BSM BONE SUBSTITUTE MATERIAL KIT
K
97
0884
RESOLUT REGENERATIVE MATERIAL
K
96
4342
CYTOPLAST GBR
K
96
0267
TBM SPONGE
K
94
0643
OSMED EPI-GUIDE
K
96
2624
RESOLUT REGENERATIVE MATERIAL
K
96
2494
PERIOGLAS - BIOGLASS BONE GRAFT PARTICULATE
K
96
2838
PERMARIDGE SYRINGE
K
96
2786
OSTEOGRAF STAINLESS STEEL SYRING
K
96
0348
OSTEOGRAF/N-300 HYDROXYLAPATITE
K
96
0368
OSTEOGRAFT/N-700 HYDROXYLAPTITE
K
96
0353
OSTEOGRAF/LD-300 HYDROXYLAPATITE
K
96
0361
PERMAMESH-D HYDROXYLAPATITE MATRIX
K
96
0164
BIO-INTERFACES, INC., BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BII-GRAFT 6140
K
95
0306
IMTEC BIOBARRIER
K
95
5096
CAPSET CALCIUM SULFATE BONE GRAFT PLASTER
K
95
4763
BIO-INTERFACES, INC,. BII-PLAST
K
95
4631
OSTEOGRAF/N-BLOCCK HYDROXYLAPATITE
K
95
2922
BIOGRAN BIOACTIVE GLASS SYNTHETIC BONE GRAFT MATERIAL
K
95
2619
BIO-OSS CERAMIC
K
95
2618
BIO-OSS
K
95
0598
BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BLL-GRAFT
K
92
4408
COLLA-TEC ABSORBABLE COLLAGEN MEMBRANE
K
95
2617
BIO-OSS
K
92
3310
OSTEOGEN (HA RESORB)
K
95
0567
BIO-APATITE 6140 HA PARTICLES
K
95
0511
BLL-FIL 6140 PARTICLES
K
94
3186
CAPSET CALCIUM SULFATE BONE GRAFT PLASTER
K
95
0165
INTERPORE IP 200 GRANULAR CORALLINE HYDROXYAPATITE BONE VOID FILLERS, 425 TO 1000 MICRONS AND 425 TO 600 MICRONS
K
93
2866
RESOLUT REGENERATIVE MATERIAL
K
94
1780
ORTHOVITA BIOGRAN
K
94
2946
OSTEOGRAF/D-100 HYDROXYLAPATITE
K
94
2212
OSTEOGRAF/LD-300 HYDROXYLAPATITE
K
93
4049
BII-PORE(TM) CANAL WALL PROSTHESIS
K
93
3688
BII-PORE
K
93
4430
BON APATITE HA PARTICLES
K
93
4947
BII-PLAST
K
93
0115
PERIOGLASS
K
92
4287
710 POROUS HA PARTICLES-BII-PORE
K
92
4288
B1018 POROUS HA BII-PORE
K
92
4286
4060 POROUS HA PARTICULES BII PORE
K
92
2487
BIO-INTERFACES 1840 POROUS HA PARTICLES-BII-PORE
K
92
1776
1840 HA PARTICLES
K
92
0508
BIO-OSS BLOCKS
K
92
1468
PERMAMESH HYDROXYLAPATITE MATRIX
K
92
1469
OSTEOGRAF/N-700 NATURAL HYDROXYLAPATITE 18-40 MESH
K
91
0432
HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER
K
90
0136
CEROS 80 (HA)
K
90
2295
OSTEOGRAF/N NATURAL HYDROXYLAPATITE, 40-60 MESH
K
89
1173
OSTEOGRAF/P PERIODONTAL HYDROXYLAPATITE, 40-60
K
88
5067
4060 HA PARTICLES
K
88
0371
BIOGLASS DENTAL ENDOSSEOUS RIDGE MAINTAINER
K
88
2098
DENTORIDGE(TM) HYDROXYYLAPATITE
K
87
3763
BIO-OSS - CERAMIC PURE NATURAL HYDROXYAPATITE
K
87
1773
BIO-OSS PURE NAT HYDROXYAPATITE ENDOSS IMPLANT
K
86
3237
HYDROXYLAPATITE BONE GRAFT MATERIAL
K
86
3176
ADDITIONAL CLINICAL USAGES FOR OSTEOGRAF/AR & AR+
K
86
2324
OSTEOGRAF/AR AND OSTEOGRAF/AR+
K
86
2061
OSTEOGRAF/AR+ PERMARIDGE HYDROXYLAPATITE, 18-40
K
86
1041
ENHANCE
K
86
0983
INTERPORE 200 POROUS HYDROXYAPATITE
K
86
1084
OSTEOGRAF/AR ALVEOLAR RID HYDROX, 18-40 MESH
K
86
1083
OSTEOGRAF/AR+(PLUS) ALVEOLAR RID HYDROX 18-40 MESH
K
85
2766
HA-1000 & HA-500 HYDROXYLAPATITE TOOTH ROOT SUBSTI
K
85
2199
OSTEOGRAF 2040 OSTEOGRAF 4060
K
85
2742
OSTEOGRAF AR ALVEOLAR RIDGE HYDROXYLAPATITE 18-40
K
85
2765
HA-2000 HYDROXYLAPATITE
K
85
2682
CALCITITE BONE GRAFT MAT/ORAL & MAXILLOFACIAL SURG
K
85
0012
ALLOTROPAT/HEYLTEX CORP. BONE GRAFTING DENSE HYDRO
K
84
3398
OSTEOGEN
K
84
2718
HYDROXYAPATITE
K
84
3154
TOOTH ROOT SOCKET GAUGE
K
84
3153
ANTERIOR ALVEOLAR RIDGE SIZER
K
84
2163
RIDGEMATRIX 20/40 MESH, PERIOMATRIX
K
84
1201
POROUS HYDROXYAPATITE BG200
K
84
0260
PERIOGRAF DURAPATITE 40-60 MESH
K
83
2509
MBS HARD TISSUE REPLACEMENT SYSTEM
K
83
0304
REPLAM HYDROXYAPATITE
K
82
1752
SYNTHOGRAFT LG-AUGMENTATION & BONE FILL
K
82
0023
CONAGRAF TM DURAPATITE CONES
K
81
3070
PERIOGRAF
K
81
1101
HYDROXYLAPATITE
K
81
0382
HYDROXYLAPATITE ALVEOLAR RIDGE MAIN
K
79
1416
PYROLITE CARBON ALVEOLAR MAINTEN IMPLANT
LZD
Joint, Temporomandibular, Implant
MMT
Resin, Root Canal Filling Containing Chloroform
MMU
Adhesive, Denture, Acacia And Karaya With Sodium Borate > 12% By Weight
MPI
Glenoid Fossa Prosthesis
MPJ
Interarticular Disc Prosthesis (Interpositional Implant)
MPL
Mandibular Condyle Prosthesis
MZW
Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief
NDP
Accessories, Implant, Dental, Endosseous
NFE
Materials, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Alveolar Ridge Augmentation
NHA
Abutment, Implant, Dental, Endosseous
NKJ
Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter
NME
Bur, Diamond Coated, Reprocessed
NOF
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
NPK
Barrier, Synthetic, Intraoral
NPL
Barrier, Animal Source, Intraoral
NPM
Bone Grafting Material, Animal Source
NPZ
Bone Grafting Material, Dental, With Biologic Component
NQA
Biologic Material, Dental
NRQ
Blade-Form Endosseous Dental Implant
NUN
Bone Grafting Material, Human Source
NUX
Cleanser, Denture, Prescription
NYD
Endodontic Kit
OAT
Implant, Endosseous, Orthodontic
NYE
Fixture Mount Kit
OFW
Restorative Instrument And Component Tray
OFY
Dental Implant Surgical Tray
OIV
Dental Amalgam
PHR
Diammine Silver Fluoride Dental Hypersensitivity Varnish
PME
External Cleaning Solution
PNP
Dental Abutment Design Software For Dental Laboratory
POW
Crown And Bridge, Long-Term Temporary, Resin
PZY
Additively Manufactured, Preformed, Resin Denture Tooth
QJK
Intraoral Camera
QRQ
Non-Irrigation Endosseous Dental Implant Drill Bits
Subpart E—Surgical Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—General Hospital and Personal Use Miscellaneous Devices
Subpart G—Miscellaneous Devices
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
DE
/
subpart-d—prosthetic-devices
/
LYC
/
K103820
View Source
REPROBONE DENTAL GRAFTING MATERIAL
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K103820
510(k) Type
Traditional
Applicant
CERAMISYS LTD
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/3/2011
Days to Decision
308 days
Submission Type
Summary