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Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
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Review Panel
Dental
Review Panel
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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
K
12
3929
BEGOPAL+
2
Cleared 510(K)
K
04
0180
CONTINUM V
2
Cleared 510(K)
K
04
0179
CONTINUM
2
Cleared 510(K)
K
03
3356
VERASOFT ES
2
Cleared 510(K)
K
03
3045
DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST
2
Cleared 510(K)
K
03
2136
WIROBOND C
2
Cleared 510(K)
K
03
1627
NANO-TICROWN
2
Cleared 510(K)
K
03
0632
PD CASTA-H
2
Cleared 510(K)
K
03
0416
CERACAST-V
2
Cleared 510(K)
K
03
0161
SUPERBOND
2
Cleared 510(K)
K
02
4214
KAVO EVEREST TITANBLANK
2
Cleared 510(K)
K
02
3499
GOLD CORE PLUS
2
Cleared 510(K)
K
02
3502
JEWEL CAST PLUS
2
Cleared 510(K)
K
02
3477
BIOLOY
2
Cleared 510(K)
K
02
1971
CERALOY
2
Cleared 510(K)
K
02
1969
CHROLOY
2
Cleared 510(K)
K
02
1965
CHROLOY SOLDER
2
Cleared 510(K)
K
02
1968
CERALOY SOLDER
2
Cleared 510(K)
K
02
0253
4 ALL (DW286A)
2
Cleared 510(K)
K
02
0898
D.SIGN 15 (DW286 B)
2
Cleared 510(K)
K
02
0183
PISCES PLUS (DW286 C)
2
Cleared 510(K)
K
02
0062
XERAFIT
2
Cleared 510(K)
K
01
1706
FLEXICAST PRIME
2
Cleared 510(K)
K
01
1705
SUPREMCAST
2
Cleared 510(K)
K
01
0381
D.SIGN 30
2
Cleared 510(K)
K
01
0069
DURABOND NON-PRECIOUS CERAMIC ALLOY
2
Cleared 510(K)
K
00
3387
AUROFILM NP
2
Cleared 510(K)
K
00
3509
FLEXICAST
2
Cleared 510(K)
K
00
3037
JEWEL CAST III
2
Cleared 510(K)
K
00
3039
GOLD CORE II
2
Cleared 510(K)
K
00
2302
SUPER 14
2
Cleared 510(K)
K
00
2300
SUPER 6
2
Cleared 510(K)
K
00
2301
SUPER 12
2
Cleared 510(K)
K
00
2299
SUPER 3
2
Cleared 510(K)
K
00
2298
SUPER 1
2
Cleared 510(K)
K
00
1798
DC TITAN
2
Cleared 510(K)
K
00
1383
SUPREMCAST V
2
Cleared 510(K)
K
00
1269
DENTALMATIC TI PROSTHESIS AND DENTALMATIC TI-A PROSTHETIC
2
Cleared 510(K)
K
00
0981
CERAMIX EZ CAST, CERAMIX EZ CAST SOLDER, CERAMIX EZ CAST FLUX
2
Cleared 510(K)
K
99
3572
CERADIUM V NON-PRECIOUS CERAMIC ALLOY
2
Cleared 510(K)
K
99
2881
HI BOND NON-PRECIOUS CERAMIC ALLOY
2
Cleared 510(K)
K
99
3344
P10 SPECIAL
2
Cleared 510(K)
K
99
2705
CERADIUM NON-PRECIOUS CERAMIC ALLOY
2
Cleared 510(K)
K
99
0235
D-SIGN VI (R&D PROJECT DW266#9)
2
Cleared 510(K)
K
99
0182
D-SIGN V (R&D PROJECT DW267#17)
2
Cleared 510(K)
K
98
4164
JELBOND NP
2
Cleared 510(K)
K
98
2094
VERABOND 2
2
Cleared 510(K)
K
97
2971
NPG + 2
2
Cleared 510(K)
K
97
3567
SOWELL COBALT-CHROME METAL ALLOY
2
Cleared 510(K)
K
97
3568
SOWELL NICKEL-CHROME NON-PRECIOUS METAL ALLOY
2
Cleared 510(K)
K
97
3569
SOWELL NICKEL-CHROME-MOLYBDENUM ALLOY
2
Cleared 510(K)
K
97
3566
SOWELL PATENTED NON-PRECIOUS METAL ALLOY
2
Cleared 510(K)
K
97
3265
VERABOND 2V
2
Cleared 510(K)
K
97
2607
PLATALLOY
2
Cleared 510(K)
K
97
2118
VERA PDN
2
Cleared 510(K)
K
97
0205
VITALLIUM 2000 ALLOY; VITALLIUM 2000 PLUS ALLOY; COBALT CHROME CASTING ALLOY
2
Cleared 510(K)
K
97
0827
PRECISE
2
Cleared 510(K)
K
96
3891
RX 96E
2
Cleared 510(K)
K
96
1720
CERAMCO CROWNS AND BRIDGES
2
Cleared 510(K)
K
95
3594
VULCAN
2
Cleared 510(K)
K
95
2866
REMATITAN TITANIUM
2
Cleared 510(K)
K
95
2867
REMANIUM:GM 700, GM 380, GM 800, GFH
2
Cleared 510(K)
K
95
2870
REMANIUM: CS & G-SOFT
2
Cleared 510(K)
K
95
2865
REMANIUM: 200,CS, 380, AND CD
2
Cleared 510(K)
K
95
0894
SUREFIRE PF+ (HIGH PALLADIUM DENTAL CASTING ALLOY FOR PORCELAIN APPLICATIONS)
2
Cleared 510(K)
K
95
0951
NEOCAST C, V, S
2
Cleared 510(K)
K
94
5712
VERABOND V
2
Cleared 510(K)
K
94
5714
VERABOND III
2
Cleared 510(K)
K
94
5713
VERABOND II
2
Cleared 510(K)
K
92
6165
CERAMCO CROWNS AND BRIDGES
2
Cleared 510(K)
K
94
0749
LPG 5/10, LPG 10/5, LPG 10/15 AND LPG 15/10
2
Cleared 510(K)
K
93
2893
VIDENT 500 ALLOY AND VIDENT 550 BE ALLOY
2
Cleared 510(K)
K
93
4758
R2+
2
Cleared 510(K)
K
93
5972
ARGELOY N.P. (V) (NON-PRECIOUS DENTAL ALLOY FOR PROCELAIN APPLICATION)
2
Cleared 510(K)
K
93
5829
ARGELOY PARTIAL (NON-PRECIOUS)
2
Cleared 510(K)
K
92
4716
NICO DENTAL ALLOY
2
Cleared 510(K)
K
93
4768
ARGELITE 81SF+
2
Cleared 510(K)
K
92
2954
R1, R2, AND R1+
2
Cleared 510(K)
K
92
6347
DUCERANIUM U
2
Cleared 510(K)
K
92
5579
VERASOFT CASTING ALLOY
2
Cleared 510(K)
K
92
2790
DEGUCAST 40
2
Cleared 510(K)
K
91
5250
WIL-PDS & WIL-PDI CASTING ALLOYS
2
Cleared 510(K)
K
92
0561
DW242-07 NON-PRECIOUS ALLOY F/ PORCELAIN FUS. MET.
2
Cleared 510(K)
K
91
5249
VERA PDS & VERA PDI
2
Cleared 510(K)
K
91
5247
NPG III CASTING ALLOY
2
Cleared 510(K)
K
91
5248
LPG CASTING ALLOY
2
Cleared 510(K)
K
91
3857
ROCATEC(R) -PLUS
2
Cleared 510(K)
K
91
1323
FLUX-N-ALL
2
Cleared 510(K)
K
90
5034
HD-4 CROWN & BRIDGE ALLOY
2
Cleared 510(K)
K
90
1552
(CP) TITANIUM AND TI6AI-4V ALLOY FOR FIXED PROSTHE
2
Cleared 510(K)
K
91
1821
THERMABOND SUPERCAST NP OR THERMABOND SUPERCAST
2
Cleared 510(K)
K
90
3538
WIRON 99 DENTAL CASTING ALLOY
2
Cleared 510(K)
K
90
3008
VIDENT 90 ALLOY AND VIDENT 95 ALLOY
2
Cleared 510(K)
K
90
0117
STELLITE COBALT/CHROMIUM BASE METAL ALLOY
2
Cleared 510(K)
K
89
6501
TECH STAR DENTAL CASTING ALLOYS (NON-PRECIOUS)
2
Cleared 510(K)
K
89
4085
TALLADIUM TILITE CERAMIC ALLOY
2
Cleared 510(K)
K
88
4257
LEVINIUM
2
Cleared 510(K)
K
88
2170
RX ASPEN
2
Cleared 510(K)
K
88
0875
VITALLIUM EQUIPOISE ALLOY
2
Cleared 510(K)
K
87
3661
CHROME-COBALT BASE DENTAL ALLOY
2
Cleared 510(K)
K
86
4826
A-SP ALLOY (SILVER-PALLADIUM CROWN & BRIDGE ALLOY)
2
Cleared 510(K)
K
86
3782
NPG NONPRECIOUS CROWN AND BRIDGE ALLOY
2
Cleared 510(K)
K
86
2930
PERFECT ONE
2
Cleared 510(K)
K
86
2822
REXILLIUM N. B. F.
2
Cleared 510(K)
K
86
2499
ULTRACAST
2
Cleared 510(K)
K
86
2870
RESISTAL P
2
Cleared 510(K)
K
86
2667
COBALT, 29.5% CHROMIUM ALLOY DENTAL BAKE-ON ALLOY
2
Cleared 510(K)
K
86
2417
NICKEL,20% CHROMIUM PORCELAIN FUSED TO METAL ALLOY
2
Cleared 510(K)
K
86
1820
BIOSIL F
2
Cleared 510(K)
K
86
1787
BIOSIL H
2
Cleared 510(K)
K
86
0437
PARTIAL DENTURE ALLOY
2
Cleared 510(K)
K
86
0217
NCM - ALPHA ALLOY (DENTAL BAKE-ON ALLOY)
2
Cleared 510(K)
K
85
4738
SPARTAN SOLDER
2
Cleared 510(K)
K
85
4878
H40 BASE METAL ALLOY
2
Cleared 510(K)
K
85
4495
GRESCO N.P. DENTAL ALLOY
2
Cleared 510(K)
K
85
4285
GDC 1453 CASTING ALLOY
2
Cleared 510(K)
K
85
3845
ALLOY B
2
Cleared 510(K)
K
85
2895
CERAMIC ALLOY NO. DW 179
2
Cleared 510(K)
K
85
3498
PERFECT 10
2
Cleared 510(K)
K
85
1515
HERAENIUM CA
2
Cleared 510(K)
K
85
0084
TRINDIUM-DENTAL MATERIAL
2
Cleared 510(K)
K
85
1569
VERA BOND NON PERCIOUS CERAMIC ALLOY
2
Cleared 510(K)
K
84
4497
AUSTENAL A-79 CROWN & BRIDGE CASTING ALLOY
2
Cleared 510(K)
K
84
4123
RX CBY
2
Cleared 510(K)
K
84
4122
RX CBG
2
Cleared 510(K)
K
84
2551
BASE METAL ALLOY
2
Cleared 510(K)
K
84
2377
MS NONPRECIOUS CROWN & BRIDGE ALLOY
2
Cleared 510(K)
K
84
1290
STELDENT - DENTAL ALLOY
2
Cleared 510(K)
K
84
0562
REX V
2
Cleared 510(K)
K
83
4560
VITEX P.D.A
2
Cleared 510(K)
K
83
3512
PARTIAL DENTURE ALLOY
2
Cleared 510(K)
K
83
3143
REXILLIUM III
2
Cleared 510(K)
K
83
3145
ZENITH
2
Cleared 510(K)
K
83
3144
REX ALLOY
2
Cleared 510(K)
K
82
3008
NOVAREX
2
Cleared 510(K)
K
82
2957
PURCAST
2
Cleared 510(K)
K
82
2947
NEPTUNE
2
Cleared 510(K)
K
82
2948
RX BIOCAST
2
Cleared 510(K)
K
82
2896
CAVIDRY
2
Cleared 510(K)
K
82
0328
NICKEL-BASED DENTAL CASTING ALLOY
2
Cleared 510(K)
K
82
0049
CERILLIUM
2
Cleared 510(K)
K
81
3243
CERAL-BASE METAL ALLOY
2
Cleared 510(K)
K
81
1258
BASE METAL ALLOY
2
Cleared 510(K)
K
81
1013
SUMMAR NON-PRECIOUS, CERAMIC ALLOY
2
Cleared 510(K)
K
81
1407
BA-93
2
Cleared 510(K)
K
81
0594
CRYSTALLOY-P
2
Cleared 510(K)
K
81
0611
FULCAST/SUMMIT CASTING ALLOY
2
Cleared 510(K)
K
81
0521
CO-SPAN 13.5 CASTING ALLOY
2
Cleared 510(K)
K
80
0371
WILL CERAM LITE-CAST B
2
Cleared 510(K)
K
78
0642
LITECAST SOLDER
2
Cleared 510(K)
K
78
0090
DENTAL ALLOY
2
Cleared 510(K)
K
77
2256
CROWN & BRIDGE ALLOY
2
Cleared 510(K)
K
77
1081
LITECAST CERAMIC
2
Cleared 510(K)
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
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
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Last synced on 6 June 2025 at 11:06 pm
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subpart-d—prosthetic-devices
/
EJH
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K860217
View Source
NCM - ALPHA ALLOY (DENTAL BAKE-ON ALLOY)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K860217
510(k) Type
Traditional
Applicant
AUSTENAL DENTAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/17/1986
Days to Decision
54 days
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
K
12
3929
BEGOPAL+
K
04
0180
CONTINUM V
K
04
0179
CONTINUM
K
03
3356
VERASOFT ES
K
03
3045
DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST
K
03
2136
WIROBOND C
K
03
1627
NANO-TICROWN
K
03
0632
PD CASTA-H
K
03
0416
CERACAST-V
K
03
0161
SUPERBOND
K
02
4214
KAVO EVEREST TITANBLANK
K
02
3499
GOLD CORE PLUS
K
02
3502
JEWEL CAST PLUS
K
02
3477
BIOLOY
K
02
1971
CERALOY
K
02
1969
CHROLOY
K
02
1965
CHROLOY SOLDER
K
02
1968
CERALOY SOLDER
K
02
0253
4 ALL (DW286A)
K
02
0898
D.SIGN 15 (DW286 B)
K
02
0183
PISCES PLUS (DW286 C)
K
02
0062
XERAFIT
K
01
1706
FLEXICAST PRIME
K
01
1705
SUPREMCAST
K
01
0381
D.SIGN 30
K
01
0069
DURABOND NON-PRECIOUS CERAMIC ALLOY
K
00
3387
AUROFILM NP
K
00
3509
FLEXICAST
K
00
3037
JEWEL CAST III
K
00
3039
GOLD CORE II
K
00
2302
SUPER 14
K
00
2300
SUPER 6
K
00
2301
SUPER 12
K
00
2299
SUPER 3
K
00
2298
SUPER 1
K
00
1798
DC TITAN
K
00
1383
SUPREMCAST V
K
00
1269
DENTALMATIC TI PROSTHESIS AND DENTALMATIC TI-A PROSTHETIC
K
00
0981
CERAMIX EZ CAST, CERAMIX EZ CAST SOLDER, CERAMIX EZ CAST FLUX
K
99
3572
CERADIUM V NON-PRECIOUS CERAMIC ALLOY
K
99
2881
HI BOND NON-PRECIOUS CERAMIC ALLOY
K
99
3344
P10 SPECIAL
K
99
2705
CERADIUM NON-PRECIOUS CERAMIC ALLOY
K
99
0235
D-SIGN VI (R&D PROJECT DW266#9)
K
99
0182
D-SIGN V (R&D PROJECT DW267#17)
K
98
4164
JELBOND NP
K
98
2094
VERABOND 2
K
97
2971
NPG + 2
K
97
3567
SOWELL COBALT-CHROME METAL ALLOY
K
97
3568
SOWELL NICKEL-CHROME NON-PRECIOUS METAL ALLOY
K
97
3569
SOWELL NICKEL-CHROME-MOLYBDENUM ALLOY
K
97
3566
SOWELL PATENTED NON-PRECIOUS METAL ALLOY
K
97
3265
VERABOND 2V
K
97
2607
PLATALLOY
K
97
2118
VERA PDN
K
97
0205
VITALLIUM 2000 ALLOY; VITALLIUM 2000 PLUS ALLOY; COBALT CHROME CASTING ALLOY
K
97
0827
PRECISE
K
96
3891
RX 96E
K
96
1720
CERAMCO CROWNS AND BRIDGES
K
95
3594
VULCAN
K
95
2866
REMATITAN TITANIUM
K
95
2867
REMANIUM:GM 700, GM 380, GM 800, GFH
K
95
2870
REMANIUM: CS & G-SOFT
K
95
2865
REMANIUM: 200,CS, 380, AND CD
K
95
0894
SUREFIRE PF+ (HIGH PALLADIUM DENTAL CASTING ALLOY FOR PORCELAIN APPLICATIONS)
K
95
0951
NEOCAST C, V, S
K
94
5712
VERABOND V
K
94
5714
VERABOND III
K
94
5713
VERABOND II
K
92
6165
CERAMCO CROWNS AND BRIDGES
K
94
0749
LPG 5/10, LPG 10/5, LPG 10/15 AND LPG 15/10
K
93
2893
VIDENT 500 ALLOY AND VIDENT 550 BE ALLOY
K
93
4758
R2+
K
93
5972
ARGELOY N.P. (V) (NON-PRECIOUS DENTAL ALLOY FOR PROCELAIN APPLICATION)
K
93
5829
ARGELOY PARTIAL (NON-PRECIOUS)
K
92
4716
NICO DENTAL ALLOY
K
93
4768
ARGELITE 81SF+
K
92
2954
R1, R2, AND R1+
K
92
6347
DUCERANIUM U
K
92
5579
VERASOFT CASTING ALLOY
K
92
2790
DEGUCAST 40
K
91
5250
WIL-PDS & WIL-PDI CASTING ALLOYS
K
92
0561
DW242-07 NON-PRECIOUS ALLOY F/ PORCELAIN FUS. MET.
K
91
5249
VERA PDS & VERA PDI
K
91
5247
NPG III CASTING ALLOY
K
91
5248
LPG CASTING ALLOY
K
91
3857
ROCATEC(R) -PLUS
K
91
1323
FLUX-N-ALL
K
90
5034
HD-4 CROWN & BRIDGE ALLOY
K
90
1552
(CP) TITANIUM AND TI6AI-4V ALLOY FOR FIXED PROSTHE
K
91
1821
THERMABOND SUPERCAST NP OR THERMABOND SUPERCAST
K
90
3538
WIRON 99 DENTAL CASTING ALLOY
K
90
3008
VIDENT 90 ALLOY AND VIDENT 95 ALLOY
K
90
0117
STELLITE COBALT/CHROMIUM BASE METAL ALLOY
K
89
6501
TECH STAR DENTAL CASTING ALLOYS (NON-PRECIOUS)
K
89
4085
TALLADIUM TILITE CERAMIC ALLOY
K
88
4257
LEVINIUM
K
88
2170
RX ASPEN
K
88
0875
VITALLIUM EQUIPOISE ALLOY
K
87
3661
CHROME-COBALT BASE DENTAL ALLOY
K
86
4826
A-SP ALLOY (SILVER-PALLADIUM CROWN & BRIDGE ALLOY)
K
86
3782
NPG NONPRECIOUS CROWN AND BRIDGE ALLOY
K
86
2930
PERFECT ONE
K
86
2822
REXILLIUM N. B. F.
K
86
2499
ULTRACAST
K
86
2870
RESISTAL P
K
86
2667
COBALT, 29.5% CHROMIUM ALLOY DENTAL BAKE-ON ALLOY
K
86
2417
NICKEL,20% CHROMIUM PORCELAIN FUSED TO METAL ALLOY
K
86
1820
BIOSIL F
K
86
1787
BIOSIL H
K
86
0437
PARTIAL DENTURE ALLOY
K
86
0217
NCM - ALPHA ALLOY (DENTAL BAKE-ON ALLOY)
K
85
4738
SPARTAN SOLDER
K
85
4878
H40 BASE METAL ALLOY
K
85
4495
GRESCO N.P. DENTAL ALLOY
K
85
4285
GDC 1453 CASTING ALLOY
K
85
3845
ALLOY B
K
85
2895
CERAMIC ALLOY NO. DW 179
K
85
3498
PERFECT 10
K
85
1515
HERAENIUM CA
K
85
0084
TRINDIUM-DENTAL MATERIAL
K
85
1569
VERA BOND NON PERCIOUS CERAMIC ALLOY
K
84
4497
AUSTENAL A-79 CROWN & BRIDGE CASTING ALLOY
K
84
4123
RX CBY
K
84
4122
RX CBG
K
84
2551
BASE METAL ALLOY
K
84
2377
MS NONPRECIOUS CROWN & BRIDGE ALLOY
K
84
1290
STELDENT - DENTAL ALLOY
K
84
0562
REX V
K
83
4560
VITEX P.D.A
K
83
3512
PARTIAL DENTURE ALLOY
K
83
3143
REXILLIUM III
K
83
3145
ZENITH
K
83
3144
REX ALLOY
K
82
3008
NOVAREX
K
82
2957
PURCAST
K
82
2947
NEPTUNE
K
82
2948
RX BIOCAST
K
82
2896
CAVIDRY
K
82
0328
NICKEL-BASED DENTAL CASTING ALLOY
K
82
0049
CERILLIUM
K
81
3243
CERAL-BASE METAL ALLOY
K
81
1258
BASE METAL ALLOY
K
81
1013
SUMMAR NON-PRECIOUS, CERAMIC ALLOY
K
81
1407
BA-93
K
81
0594
CRYSTALLOY-P
K
81
0611
FULCAST/SUMMIT CASTING ALLOY
K
81
0521
CO-SPAN 13.5 CASTING ALLOY
K
80
0371
WILL CERAM LITE-CAST B
K
78
0642
LITECAST SOLDER
K
78
0090
DENTAL ALLOY
K
77
2256
CROWN & BRIDGE ALLOY
K
77
1081
LITECAST CERAMIC
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
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
/
EJH
/
K860217
View Source
NCM - ALPHA ALLOY (DENTAL BAKE-ON ALLOY)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K860217
510(k) Type
Traditional
Applicant
AUSTENAL DENTAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/17/1986
Days to Decision
54 days